P-NEB USER GUIDE 2008A
Contents
1. Manipulation chest wall such as cupping percussing and vibration to facilitate lung function initial demonstration and or evaluation DESCRIPTION Subsequent Page 24 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide IX Troubleshooting Cause Action e P NEB stops percussing 1 2 3 e No aerosol 1 2 e Percussion too strong 1 2 e Percussion too soft 1 2 xX Ordering I nformation Leak in connection look for pressure leak at gas connections gas supply source etc Not enough flow increase flow or change gas source Modulator stuck pistion is stuck in closed position puch open and clean Missing Baffle replace baffle Low on solution need 3 to 5mL solution to aeroslize Too much flow reduce flow Amplitude too high adjust pressure amplitude dial out for lower amplitude percussion Not enough flow increase flow Amplitude too low adjust pressure amplitude dial in for higher amplitude percussion Accessories Product Case Description Quantitiy O tubing PercussiveNEB PNB 4030 Page 25 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide XI Quick Guide Add medication Step 1 Add the medication Remove the modulator and nebulizer top ensure that the baffle is in place Place 1 mL solution for every minute of treatment NOTE The device will nebulize about 15 mL in 20 minutes with 32. The PercussiveNEB was working fine on prior treatments and is now not cycling well What s wrong Can connect the PercussiveNEB directly to a wall source of 50 PSIG All have are 15 L min flowmeters How can I use the PercussiveNEB have a patient who needs to use the PercussiveNEB at home Will it work with the Pulmoaide Answer No this is not a problem It occurs when ad justing the flow to a setting that produces a high rate of cycling during exhalation The flow rate is set too high Reduce the flow If you are connected directly to a 50 PSIG source you will have to use a flow meter or a pressure regulator It is important to assemble the PecussiveNEB tightly If a large leak is present it will not work as well This is particularly important after cleaning Be sure the nebulizer cap is screwed on tightly and that the modulator has been pushed firmly into place Lastly ensure that you are providing adequate flow It depends As long as the PercussiveNEB is cycling during exhalation at a rate appropriate for clearance and is well tolerated by the patient then the flow is acceptable If not a flow meter will need to be used All float ball type 15 L min flowmeters tested by VORTRAN Medical Technology 1 will provide sufficient flow when dialed all the way open Under such circumstances the ball indicates a flow only slightly higher then 15 L min but it is actually delivering a lot mo
3. Rev 3 5 2008 USER S GUIDE PercussiveNEB P NEB P NEB is a high frequency intrapulmonary percussive nebulizer intended for the clearance of endobronchial secretions TABLE OF NTENT Table of Contents 1i 0 6402 sees eae Ae ee nne 1 I Functional and Operational Characteristics 2 Figure 1 Airway Clearing Technique 668 2 Il Clinical Considerations c cee ceee eect eee eee eee ee 3 Figure 2 Connect P NEB to a Flowmeter 4 Figure 3 Component Description cceeeeee ee 5 III Protocol Setup Instructions PercussiveNEB 6 IV Cautions and WarningS sssssssssssssseeerrrrrrnrrrreressere 12 V P NEB COMPEt NCY cocccrinicocnein ecm aea 13 VI Frequently Asked Questions ccceeee eee e eee 14 VII Clinical Reference sssssisssssssserrrrrrrrrrrrrrnsnrrerrrrrn 16 VIII Coding Information ccc csvcccceies ves scctaed eeasiaaddriex eis 24 IX TOUBIESHOGLING socigs oi loees eA Arne te ed 25 X Ordering Information cicsescsses ei Aavtesvascadaevieareiaes 25 XI Quick Guide 2s setts ret eet edie eg 26 VORIRAN Medical Technology 1 Inc 21 Golden Land Court Sacramento CA 95834 2426 Tel 800 434 4034 www vortran com Fax 916 648 9751 office vortran com VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide l Functional and Operational Characteristics The Percuss
4. VORTRAN Medical Technology 1 Inc was operated at 35 PSIG approximately 60 L min device flow A50 PSIG compressed air source was used A trained respiratory care practitioner operated the devices and recorded pressure waveforms RESULTS The results of this evaluation are summarized below with flow waveforms Device f Hz PIP cm H 0 OTV m OTV m MV L IPV 1 40 PSIG 5 27 6442 85 6 3 8 221 3 4 2 66 IPV 1 20 PSIG 7 23 2 0 5 28 2 0 6 148 7 2 9 62 PT HF 35 PSIG 11 21 6 0 5 22 2 1 7 61 8 2 1 40 IPV 1 40 PSIG IPV 1 20 PSIG PT HF 35 PSIG FLOWRATE L MIN Flow L min 1 i 1 TIME SEC TIME SEC TIME SEC DISCUSSION The results indicate that oscillation frequencies vary slightly depending on the setting of the devices The oscillation frequency f for the IPV 1 was from 5 to 7 Hz and the PT HF was at 11 Hz The exhalation Minute Volume MV OTV x f delivered by the IPV 1 was 62 EXHL EXHL to 66 liters per minute at various frequencies In comparison the PT HF delivered about 40 liters per minute at higher frequencies CO
5. Inc Rev 3 5 2008 P NEB User s Guide V P NEB Competency How to set up and use the PercussiveNEB a new and unique single patient intrapulmonary percussive ventilation device used for clearing endobronchial secretions from patients airways tiv 1 To be able to set up clean and care for the PercussiveNEB and know the optimal flow setting and gas source requirements 2 To understand the mechanism of intrapulmonary percussion ventilation frequency 11 to 30 Hz and pressure amplitude PIP and PEP 3 To know the characteristics of the aerosol components medication and saline of the PercussiveNEB Tr leshooting the Per iveNEB 1 The flow is the only power source for the PercussiveNEB Higher flow means more percussive effect and higher frequency True False 2 If the nebulizer has an output of 1 mL min and there is still liquid in the reservoir after a 20 minute treatment should all the liquid be gone Yes No After completion of the PercussiveNEB competency the Respiratory Care Practitioner should be able to set up the PercussiveNEB and troubleshoot problems that may arise during its use a Page 13 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VI FAQ Frequently Asked Questions Question The PercussiveNEB is cycling occasionally during inhalation Is this a problem The PercussiveNEB is cycling primarily dur ing inhalation What is wrong
6. 5 mL of residual Connect tubing Set desired flow Step 2 Connect the gas supply tubing to the Step 3 Adjust the flow to PercussiveNEB the desired setting Occlude the mouthpiece to verify that the device is operating The higher the gas flow the higher the frequency The lower the flow the lower the fre Begin patient treatment and Step 4 Instruct the patient to create a seal around the mouthpiece and breathe through the mouth not the nose The P NEB will cycle during inhalation and exhalation Adjust amplitude and flow for the desired frequency Step 5 Adjust the amplitude and flow to accommodate the patient s needs and breathing patterns For best results start T ENLARGED at the SOFT setting and gradually increase to the HARD setting This Quick Guide is intended to help you gain a general understanding of the PercussiveNEB product Please be certain to read understand and follow the information listed in this User s Guide before using this product 2008 VORTRAN Medical Technology 1 Inc Sacramento California U S A Page 26
7. dysrhythmia during therapy Equipment 6 3 1 PercussiveNEB device 6 3 2 Nippled oxygen tubing comes with device 6 3 3 Gas inlet CA or O 6 3 4 Flowmeter Device Set up 6 4 1 Remove PercussiveNEB from packaging 6 4 2 Place prescribed amount of medication into nebulizer and dilute with saline to obtain desired total volume of liquid NOTE The aerosol output of the PercussiveNEB is dependent on the patient s breathing pattern The patient entrains air through the nebulizer during inhalation allowing for the maximum dose of medication There should be 1 mL of fluid in the nebulizer reser voir for approximately every 1 minute of treatment NEBULIZER RESERVOIR 20 mL 6 4 3 Connect oxygen tubing to flow source and set initial flow using a flow meter that covers the range from 0 75 L min such as a Timeter Classic Series Flowmeter 0 75 L min Model A 75 for air or Model O 75 for oxygen Allied Healthcare Products Inc Orders 6 5 1 Check patient s chart for airway clearance order including medica tions and frequency CONNECT Page 8 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Illi Protocol P NEB continued 6 6 6 7 Patient Instructions Assessment 6 6 1 Explain the purpose and rationale to the patient family prior to initiating treatment Continue to assess supplement the patient s understanding of the therapy at subsequ
8. manual chest physiotherapy CPT with respect to acute changes in pulmonary function sputum production and pulse oximetry in patients with cystic fibrosis CF Design Randomized crossover Setting University affiliated community based CF center Participants Ten clinically stable patients with CF age range 10 to 21 years mean age 15 3 years with Shwachman scores from 55 to 95 mean 75 Interventions Two treatment regimens were used 2 5 mg of albuterol delivered via updraft nebulizer followed by standard CPT and 2 5 mg of albuterol delivered via the PTHF device without CPT Results Outcome measures included pulmonary function test PFT results 4 h after treatment and quantita tive sputum production during the 4 h after treatment Pulse oximetry was performed during treatment A patient satisfaction questionnaire was administered at the end of the study No PFT parameters were significantly changed 4 h after CPT or PTHF although there was a trend to decreasing residual volume after both treatments There was a trend for more sputum production after PTHF compared to CPT but this did not reach statistical significance There were no episodes of hemoglobin oxygen desaturation during or after either treatment One patient had minor hemoptysis after CPT No adverse effects occurred after PTHF Eight patients found the PTHF device easy to use and six patients would prefer the PTHF device to CPT Conclusions The PTHF device appears to be a safe an
9. parallel comparative trial of the IPV versus standard manual chest physiotherapy in 16 CF children and adults No significant differences in spirometric measures numbers of hospitalizations use of oral or IV antibiotics or anthropometric measurements were detected between the standard aerosol chest physiotherapy group and the IPV group over the duration of the trial Patient acceptance as determined by participant survey was good The device appeared to be safe and durable It was concluded that the IPV is as effective as standard aerosol and chest physiotherapy in preserving lung function and anthropometric measures and there was no difference in the use of antibiotics and hospitalizations Page 20 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued COMPARISON OF AIRWAY PRESSURE AND OSCILLATION FREQUENCY OF FOUR AIRWAY CLEARANCE DEVICES D Blackney and B Chipps Cystic Fibrosis Center Sutter Memorial Hospital Sacramento CA USA BACKGROUND Factors that improve mucus clearance rate are important for patients with cystic fibrosis Studies have shown that high frequency oscillation enhances tracheal mucus clearance Comparison of airway pressure waveforms and oscillation frequency for four airway clearance devices was recorded to compare the operational characteristics of intrapulmonary percussion effects METHODS Each device was connected to a pressure transducer on the mouthp
10. patient should be encouraged to exhale slowly and for as long as possible Because the pressure bursts provide some measure of ventilatory support patients will usually be comfortable exhaling for longer period of time Ini tially some patients may be tense so the P NEB may not oscillate as desired However as the patient relaxes during exhalation the P NEB will be able to function properly Every patient is different so adjustment of flow and pres sure settings training and good clinical judgment are all important Some patients will allow their cheeks to puff out with each pressure burst of the P NEB This should be strongly discouraged because it reduces the pres sure effect reaching the lungs The P NEB nebulizer may be filled with up to 20 mL of liquid Physicians should select medication carefully to achieve optimal benefits In any event it is important that the patient receives moisture during the treatment Page 3 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Clinical Considerations continued The P NEB nebulizer has an output during inhalation of approximately 1 mL min which depends on the patient s inhalation efforts It is recommended that the P NEB reservoir be filled with 1 mL of inhlation solution for every minute of aerosol treatment Because on exhalation when the patient should not be receiving any aerosol the output is much less Therefore the average output during the entire tre
11. 0 hour 30 00 hour Labor cost per TX 7 50 22 50 15 00 Equipment P NEB Nebulizer Flutter amp Nebulizer Cost of equipment 72 00 2 00 55 00 Estimated Cost Daily Based on QID Cost 1 day 72 7 50 X 4 102 2 22 50 X 4 92 55 15 X 4 115 Cost 2 days 72 7 50 X 8 132 2 22 50 X 8 182 55 15 X 8 175 Cost 3 days 72 7 50 X 12 162 2 22 50 X 12 272 55 15 X 12 235 BENEFITS COMPARISON P NEB P D amp P Flutter with Aerosol with Aerosol TX with Aerosol TX Needs therapist No Yes No Therapy consistency Yes No No Ease of use Fully automatic Needs therapist Needs adequate TV amp Q Patient tolerance Good Not tolerated by all Good PULMONARY FUNCTION AND SPUTUM PRODUCTION IN PATIENTS WITH CYSTIC FIBROSIS A PILOT STUDY COMPARING THE PERCUSSIVETECH HF DEVICE AND STANDARD CHEST PHYSIOTHERAPY John H Marks MD FCCP Karyl L Hare RN CDE Robert A Saunders RRT and Douglas N Homnick MD MPH FCCP et al American College of Chest Physicians Chest 2004 125 1507 1511 From the Pediatric Pulmonary Division Department of Pediatrics Michigan State University Kalamazoo Center for Medical Studies Drs Marks and Homnick and Ms Hare and Pulmo nary Function Laboratory Bronson Methodist Hospital Mr Saunders Kalamazoo MI Study objective To compare the PercussiveTech HF PTHF device Vortran Medical Technology 1 Sacramento CA to standard
12. NCLUSIONS The flow waveform of the PT HF is compatible to that of the IPV 1 PIP is essentially the same with the PT HF oscillating at higher frequencies and at a lower pressure The MV xy results suggest that patients were ventilated during the exhalation phase through the use of high frequency oscillation Further studies should be done to evaluate the impact of volume delivered on patients during exhalation and on the effectiveness of airway clearance at various frequencies Supported by VORTRAN Medical Technology 1 Inc Accepted for presentation at 45 AARC International Respiratory Congress in Las Vegas Nevada December 13 16 1999 Page 22 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued In vitro Comparison of the Operational Characteristics of the PercussiveTech HF and Percussionaire IPV SUMMARY The aerosol output and particle size distribution for the PercussiveTech HF and Percussionaire IPV are essentially identical using three common inhalation solutions The pressure waveforms show that the PT HF oscillates at a higher frequency 6 14 Hz than IPV which could improve secretion mobilization and clearance High frequency chest wall oscillation HFCWO and intrapulmonary percussive ventilation IPV are as effective as chest physical therapy and postural drainage CPT amp PD INTRODUCTION The quality particle size distribution and quantity outp
13. Remove modulator from main column Rotate nebulizer top counterclockwise Y turn and lift up to remove Remove baffle from reservoir Wash all components using soapy water detergent and rinse throughly after every treatment Allow to air dry before reassembly Clean the modulator by running water through Cleaning the smaller port using a Rod cleaning rod to push the piston up and down in the large port Allow water to flush through the modulator cleaning the piston Shake dry Piston and repeat Assembly lt i The PercussiveNEB W performance will de grade if the modulator is not adequately cleaned 6 10 3 To reassemble 6 10 3 1 6 10 3 2 6 10 3 3 Reassemble in the reverse order of Steps 1 through 3 Make sure all components are firmly in place The PercussiveNEB is now ready to use Nebulizer Top Se Modulator Mouthpiece va Nebulizer Pa Ge plitude reservoir a Dial with baffle inside Main column Page 11 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide IV Cautions and Warnings Cautions 1 Positive End Expiratory Pressure PEEP is intrinsic to this device Typical baseline pressure can reach up to 8 cm H O 2 To be used only by persons having adequate training Warnings Not for patients receiving continuous ventilation Page 12 GERTBAM Mesias Tesbnology 1
14. al liquid consumption rate of the devices were about 1 mL min Output 20 PSIG 35 PSIG PercussiveTech HF 0 4 0 09 mL min 0 5 0 07 mL min Percussionaire IPV 0 4 0 00 0 3 0 05 The particle size distribution MMAD and GSD sampled over the duration of operation was essentially the same for all three drugs delivered in mL min There was no significant difference in the aerosol output characteristics for the new device PercussiveTech HF compared to the predicate device Percussionaire IPV in all modes of operation 20 or 35 PSIG hard and easy settings Particle Size Distribution 20 PSIG 35 PSIG MMAD mm GSD MMAD mm GSD PercussiveTech HF 0 5 0 09 1 9 0 15 0 5 0 06 1 9 0 20 Percussionaire IPV 0 5 0 06 1 8 0 14 0 4 0 05 1 6 0 29 The pressure waveforms as recorded indicated that PT HF is capable of cycling at a higher oscillating frequency than IPV The peak pressure for PT HF should not exceed 20 cm H O when properly operated while IPV was measured at up to 25 cm H O Pressure waveforms Peak pressure cm H O Frequency cycles per minute PercussiveTech HF Maximum 20 Up to 840 Percussionaire IPV Up to 25 Over 200 CONCLUSIONS In vitro testing of aerosol characteristics comparing the PercussiveTech HF and the Percussionaire IPV shows that the devices provide patients with equivalent aerosol quantity and quality and are therefore substantially equivalent REFERENCE 1 M King D M Phillips D Gr
15. ardiac failure Both patients required reintubation and mechanical ventilation EXPERIENCE PN appears to be a viable alternative to our traditional bronchial hygiene regimen though a more thorough investigation should be undertaken CONCLUSIONS Treatment of atelectasis in post operative cardiac surgery patients with PN appears to be a more effective and efficient use of departmental resources than traditional bronchial hygiene procedures Page 16 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued Finder Jonathan MD Airway Clearance Techniques Trends in the Treatment of Lung Diseases Respiratory Magazine Issue November 2007 CPT has been the standard for CF care since the 1960s but newer techniques are finding acceptance too In respiratory medicine one constant theme is the importance of airway clearance in maintaining health Airway secretion clearance consists of two linked systems mucociliary clearance and cough clearance Oscillation Devices High frequency chest wall oscillation CWO as a term should not be used interchangeably with HFCC High frequency CWO refers to the Hayek Oscillator Breasy Medical Equipment Charlotte NC which is a negative pressure ventilator that uses a cuirass interface around the chest Just one study 15 using this device in CF has been published and the authors found that it was not as effective as techniques using the active cy
16. at liquid is present in the nebulizer reservoir during the entire course of treatment The PercussiveNEB is single patient multiple use and totally disposable Under normal operating condition your device should last about 100 hours of operation If you do two 15 minutes per day it will last about 90 days Page 15 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference RL Chatburn HIGH FREQUENCY ASSISTED AIRWAY CLEARANCE Respiratory Care 2007 52 9 1224 1235 Summary High frequency airway clearance assist devices generate either positive or negative transrespiratory pressure excursions to produce high frequency small volume oscillations in the airways Intrapulmonary percussive ventilation creates a positive transrespiratory pressure by injecting short rapid inspiratory flow pulses into the airway opening and relies on chest wall elastic recoil for passive exhalation High frequency chest wall compression generates a negative transrespiratory pressure by compressing the chest externally to cause short rapid expiratory flow pulses and relies on chest wall elastic recoil to return the lungs to functional residual capacity High frequency chest wall oscillation uses a chest cuirass to generate biphasic changes in transrespiratory pressure In any case positive or negative pressure pulses or both the general idea is get air behind secretions and move them toward the larger airways wher
17. atment will be less than 1 mL min Using 20 mL in the nebulizer reservoir there will generally be residual liquid left after a 15 20 minute treatment The gas flow required to operate the P NEB is typically about 60 L min This depends on the patient and the frequency desired Generally more airflow will increase the frequency The most common flowmeters are 15 16 L min float type flowmeters Timeter Puritan Bennett etc When these flowmeters are opened all the way the float ball appears to ride just above the 15 16 L min mark but in fact is delivering a much higher flow when connected to a P NEB In general the clinician may vary the flow to what ever value is desired If the P NEB is oscillating primarily during exhalation at an acceptable frequency then the P NEB is receiving the appropriate flow The PercussiveNEB improvements in ease of use durability dependability and performance attributes has resulted in a device that is more user friendly reliable and is adjustable to patient needs The PercussiveNEB s pressure dial allows users to set airway pressure oscillation amplitude for individual comfort It is also quieter able to oscillate over a wider frequency amp pressure range and is easier to operate within the source flow range The PercussiveNEB is designed to spies ee he spa eee Figure 2 Connect P NEB to a flowmeter 1800 cycles per minute for use in the removal of mucus from the lungs of patients with retained en
18. be used with compressed air or oxygen The P NEB may be cleaned by washing with mild soap detergent followed by rinsing with water and allowing to air dry see instructions Figure 3 Component Description Nebulizer Top Ss Modulator Mouthpiece Nebulizer reservoir with Amplitude baffle inside Dial Main column Page 5 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Iil Protocol Setup Instructions PercussiveNEB HIGH FREQUENCY INTRAPULMONARY PERCUSSIVE NEBULI ZER Policy Number Department Date Adopted Dates Revised Dates Reviewed h a 1 0 2 0 3 0 Policy Use of the intrapulmonary percussive nebulizer in an acute care hospi tal setting This policy is intended for patients meeting clinical indica tions for use of the percussive device This policy is further intended for use by licensed hospital personnel trained in the use of aerosol pressure delivery devices This policy is applicable only upon individual physician order or with established medical staff approved clinical protocols For additional information refer to the manufacturer s oper ating manual Purpose To provide clinically appropriate recommendations for the use of the P NEB device including clinical indications device set up bedside appli cation potential hazards and documentation Clinical Logic New Device Policy Intrapulmonary Percussive Vent
19. cle of breathing they concluded that high frequency CWO was not an effective airway clearance modality in CF exacerbations Just as HFCC oscillates the air within the lung handheld devices that oscillate a column of air within the airway help to shear secretions away from the wall of the airway and help mobilize them for expectoration They are similar in function to HFCC One difference though is that handheld oral airway oscillators generally provide some positive airway pressure to help maintain airway patency during breathing Therefore they are often discussed in the context of PEP The first reports 16 on oral airway oscillation demonstrated an increase in expectorated sputum volume compared with conven tional CPT The original device Flutter Axcan Pharma Birmingham Ala used a metal ball that oscillated based on gravity and therefore was quite positionally sensitive Later devices used magnetic attraction to open and close the valve Acapella Smiths Medical Waukesha Wis or a hand cranked mechanism to open and close a valve Quake Thayer Medical Corp Tucson Ariz thereby rapidly opening and closing the airway s opening during expiration The hand cranked device also has the advantage of allowing airway oscillation during the inspiratory phase and it does not rely on a high flow rate for function This device may be more useful in patients with more severe obstructive defects No head to head studies of these devices have ever been pe
20. d effective method of airway clearance in CF patients in this small pilot study Page 18 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued J H Marks D N Homnick K Hare D Cucos THE PERCUSSIVETECH HF COMPARED TO THE FLUTTER DEVICE IN CYSTIC FIBROSIS PATIENTS A SIX MONTH PILOT STUDY Presented at 2001 North American Cystic Fibrosis Conference Orlando World Center Marriott Orlando Florida Oct 25 28 2001 Airway clearance devices such as the Flutter or Intrapulmonary Percussive Ventilator are accepted airway clearance methods for CF patients The PercussiveTech HF PTHF is an intrapulmonary percussive treatment device that also delivers a large volume 20ml aerosol The PTHF oscillates primarily during exhalation providing intrapulmonary percussion at 6 to 14 Hz with positive expiratory pressure of 10 20 cm H20 In a pilot study of the PTHF device we showed safety and effectiveness compared to standard chest physiotherapy Aims This study compared the longterm effects of twice daily use of the PTHF device with the Flutter device in patients with CF Outcome measures included FEV 1 primary FVC FEF25 75 number of days of hospitalization lost school or work and IV antibiotic use A patient satisfaction questionnaire was given to the PTHF group Methods Sixteen patients were randomized to either Flutter 3F 5M or the PTHF 4F 4M At enrollment spirometry and Shwac
21. dobronchial secretions The pressure amplitude per oscillation varies with the frequency and the patient but typically ranges from 20 to 40 cm H O These peak pressures are difficult for the clinician to monitor with a manometer because the pressure bursts cycle so quickly ecto aacetct u Page 4 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Clinical Considerations continued The percent time a positive pressure burst is being delivered to the patient per oscillation is 25 33 This is equivalent to an 1 E ratio ranging from 1 3 to 1 2 This ratio is important because it allows sufficient time for lung and lymph tissue to return to its resting state between pressure bursts The volume of gas delivered per pressure burst ranges from 35 to 75 mL depending on frequency and flow rate The pneumatic capacitor is designed to prevent more then 75 mL per pressure burst regardless of the patient or settings When using medication with the P NEB Nebulizer the clinician should first add the desired medication to the reservoir and then top off to 15 to 20 mL by adding the necessary volume of saline or respiratory quality water Treat ment times are typically 15 to 20 minutes It is important when reassembling the P NEB to screw the nebulizer cap on securely and press the modulator into place firmly If large leaks exist the P NEB will not function well The P NEB may
22. e significant pressure amplitude which may be beneficial along with the high frequency airway oscillation Supported by VORTRAN Medical Technology 1 Inc Accepted for presentation at 13 Annual North American Cystic Fibrosis Conference in Seattle Washington October 7 10 1999 Page 21 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued COMPARISON OF MINUTE VOLUME DELIVERED WITH HIGH FREQUENCY VENTI LATION USING TWO AIRWAY CLEARANCE DEVICES David A Blackney RCP RRT Pulmonary Services Sutter Children s Center Sacramento CA USA BACKGROUND High frequency ventilation has been used in devices to create intrapulmonary percussive effects and promote airway clearance Two percussive devices were evaluated and the flow and volume waveform characteristics were compared for high frequency oscillation The parameters important for intrapulmonary percussive type ventilation are f oscillation frequency Hz proximal PIP Peak Inspiratory Pressure cm H O OTV Oscillatory Tidal Volumes ml and MV Minute Volume Liters during inhalation and exhalation METHODS Each device was connected to a pressure tap and a flow sensor proximal to the mouthpiece to record pressure and flow waveforms using a computer data acquisition system sampling pressure at 100 Hz Model IPV 1 Percussionaire Corp was operated at both 20 and 40 PSIG at EASY setting and PercussiveTech HF
23. e they can be coughed up and expectorated These techniques have become ubiquitous enough to constitute a standard of care Yet despite over 20 years of research clinical evidence of efficacy for them is still lacking Indeed there is insufficient evidence to support the use of any single airway clearance technique let alone judge any one of them superior Aside from patient preference and capability cost effectiveness studies based on existing clinical data are necessary to determine when a given technique is most practical Key words high frequency airway clearance secretion removal intrapulmonary percussive ventilation high frequency chest wall compression high frequency chest wall oscillation Respir Care 2007 52 9 1224 1235 2007 Daedalus Enterprises Robert L Chatburn RRT NPS FAARC is affiliated with the Section of Respiratory Care Cleveland Clinic Cleveland Ohio and with the Department of Medicine Lerner College of Medicine Case Western Reserve University Cleveland Ohio PILOT STUDY PERCUSSIVE NEBULIZER VS TRADITIONAL BRONCHIAL HYGIENE THERAPY FOR TREATMENT OF POST OPERATIVE ATELECTSIS IN CARDIAC SURGERY PATIENTS John Garcia RRT Kasem Loui RRT NPS Luis Moreta Sainz MD Kaiser Permanente Los Angeles Medical Center Los Angeles CA Presented at 50 AARC International Rspiratory Congress in New Orleans LA Dec 4 7 2004 BACKGROUND Kaiser Permanente Los Angeles Medical Center is the regional tertiary care cente
24. e were no differences between groups in the mean number of hospital or home IV antibiotic days Patient satisfaction with the PTHF treatments was good with 67 of patients willing to continue using the PTHF instead of other airway clearance methods Conclusions The PTHF device was well tolerated and generally well accepted as as an airway clearance method by CF patients in this 6 month pilot study The PTHF may be as effective as the Flutter device however larger studies are needed to assure the long term effectiveness Marks JH Homnick DN Pediatr Pulmonol 1999 Suppl 19 290 Supported by Vortran Medical Technolog 1 Inc Page 19 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued Marks John H Hare KL Homnick DN PULMONARY FUNCTION AND SPUTUM PRODUC TION IN PATIENTS WITH CYSTIC FIBROSIS A PILOT STUDY COMPARING THE PERCUSSIVETECH HF DEVICE AND STANDARD CHEST PHYSIOTHERAPY 1 Michigan State University Kalamazoo Center for Medical Studies Kalamazoo MI USA Accepted for presentation at 13 Annual North American Cystic Fibrosis Conference in Seattle Washington October 7 10 1999 Abstract Manual chest physiotherapy with gravity assisted drainage CPT continues to be the standard method of airway clearance for patients with cystic fibrosis CF While CPT has long been shown to aid in clearance of pulmonary secretions in CF patients compliance in the daily regim
25. ens of therapy are often an issue due to time involved and the need for assistance in such therapy Several devices have been shown to be effective in aiding airway clearance in CF patients including positive expiratory pressure PEP the flutter device high frequency chest wall compression vest and the intrapulmonary percussive IPV We have previously reported on the effectiveness of the IPV com pared to CPT and the flutter device This study compares a new airway clearance device the PercussiveTech HF PTHF with CPT in patients with CF The PercussiveTech HF device delivers rapid mini bursts of air intrapulmonary percussion with high volume aerosol delivery Ten clinically stable patients with CF age 10 to 21 years were randomized to receive PTHF or CPT regimens on one day with crossover to the alternate treatment one week later Regimens included 2 5 mg albuterol in 2 cc NS by standard nebulizer followed by standard chest physiotherapy using CFF guidelines or 2 5 mg albuterol in 15 20 cc NS by the PTHF device without CPT Compressed air was used for the standard nebulizer and the PTHF and pulse oximetry was monitored during each treatment Baseline pulmonary function PFTs including FVC FEVI FEF25 75 TLC RV were obtained prior to each treatment Repeat PFTs were performed 4 hours after completing each regimen and sputum was collected over the 4 hour period Sputum was collected with the use of cotton wool dental dams Sputum wet and d
26. ent treat ments 6 6 2 Position the patient in an upright comfortable position and provide appropriate supplemental O as indicated to keep Sp O gt 92 or as prescribed 6 6 3 Patient pre treatment assessment will include full Respiratory Care Assessment with subsequent reassessment q day Instructions 6 7 1 Perform a FUNCTIONAL CHECK by occluding the mouthpiece and adjusting flow until oscillation begins Patients will require greater flow during treatment DO NOT use if device fails to oscillate NOTE The normal flow rate for PercussiveNEB is 60 L min 25 The majority of the flow is used for operating the internal components and is not delivered to the patient 6 7 2 Place the mouthpiece in patient s mouth Instruct the patient to breathe through the mouth not the nose Best results are achieved when the patient is relaxed and breathing normally The PercussiveNEB will oscillate during exhalation and inhala tion 6 7 3 Adjust flow rate as required until the modulator piston is heard or seen to be oscillating during exhalation For best results adjust the flow to accommodate patient s comfort and breathing pattern ADJUST FLOW RATE i CD rttactoateae Page 9 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Ilil Protocol P NEB continued 6 7 4 Adjust oscillating amplitude as needed for patient s comfort and
27. hman score were obtained All subjects then completed one week of twice daily Flutter treatments After day 7 baseline spirometry was obtained the PTHF group started twice daily treatments while the Flutter group continued twice daily Flutter treatments All patients received 2 5mg of albuterol in saline 20ml in the PTHF group and 3ml in the Flutter group with each treatment Spirometry was repeated every 4 weeks until the end of the study at 24 weeks Pulmonary exacerbations requiring hospitalization or home IV antibiotics were noted PTHF questionnaires were completed at each visit Results Fifteen patients completed the 24 week study 8 Flutter 7 PTHF One became pregnant and was excluded Both groups had a similar mean age 95 confidence interval CI Flutter 14 1 10 5 18 PTHF 10 9 8 4 13 3 and Shwachman score Flutter 72 6 62 83 PTHF 79 6 68 91 There were no significant differences between groups at day 7 baseline for mean per cent predicted FEV1 Flutter 56 41 71 and PTHF 75 6 53 98 p 208 or FVC Flutter 78 60 96 PTHF 90 6 70 111 p 292 or FEF25 75 Flutter 30 16 44 and PTHF 58 28 89 p 0513 At week 24 there were no significant differences between groups in FEV 1 p 208 FVC p 292 or FEF25 75 p 126 Within groups there is no significant difference between baseline and week 24 for FEV1 Flutter p 98 PTHF p 471 FVC Flutter p 717 or the PTHF group p 149 or FEF25 75 Flutter p 697 PTHF p 29 Ther
28. iece and pressure waveforms were recorded using a computer sampling at 300 Hz Devices were operated by a trained respiratory care practitioner and pressure waveforms were recorded RESULTS The results of this evaluation are summarized below with pressure waveforms Peak Pressure Amplitude Frequency Device cm H20 cm H20 cycle per minute Percussionair IPV 17 26 10 17 360 540 PercussiveTech HF 15 19 8 11 720 840 Flutter 20 24 2 5 1200 1800 Cornet 15 23 3 7 1080 1700 Percussionaire IPV PercussiveTech HF Flutter Cornet 30 25 20 mi uN F 2 W cc gt D a W cc oa 012345 0 1 TIME SEC TIME SEC DISCUSSION The results indicated that peak pressure for all devices ranged from 15 26 cm H O depending on the devices setting and patient exhalation effort However the pressure amplitude varied greatly for devices using external gas source 8 17 cm H O vs patient s own effort 2 7 cm H O The oscillation frequencies also vary greatly with these two classes of devices CONCLUSIONS These results suggest that patient s own effort can generate high frequency airway oscillation but very little pressure amplitude is generated Devices with external gas source can generat
29. ilation is a form of physical therapy administered to the Pulmonary Airways by a pneumatic device called a High Frequency Intrapulmonary Percussive Device PercussiveNEB The patient breathes through a mouthpiece which delivers preset driving pressure and frequency The PercussiveNEB automatically triggers during exhalation to provide intrapulmonary percussion at 11 to 30 Hz 660 to 1800 cycles per minute The PercussiveNEB delivers PEEP at 2 to 8 cm H O aerosol rate during inhalation of 1 mL min with aerosol particle size distribution of 2 to 4 mm MMAD During the per cussive bursts of air into the lungs a continued wedge pressure is maintained while a high velocity inflow opens airways and enhances endobronchial secretion mobilization Moreover the P NEB is a dispos able unit that is useful in such areas as Isolation and Nuclear Medicine Page 6 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Ill Protocol P NEB continued 4 0 5 0 6 0 Procedure 4 1 Indications 4 2 Mobilization of retained endobronchial secretions 4 3 Resolution of diffuse patchy atelectasis 4 4 Acute pulmonary edema 4 5 Cystic Fibrosis Contraindications 5 1 Absolute 5 1 1 tension pneumothorax 5 1 2 acute or high potential of pulmonary hemorrhage 5 1 3 not for patients receiving continuous ventilation 5 2 Relative 5 2 1 history of pneumothorax 5 2 2 recent lobectomy pneumonectomy 5 2 3 cardiovascular insufficie
30. iveNEB is an intrapulmonary percussive treatment device that incorporates a nebulizer to deliver aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial se cretions During inhalation the patient entrains high density aerosol from the nebulizer with high frequency intrapulmonary percussion for enhance aerosol deposition The moisture and the medication in the aerosol help thin and mobilize secretions During exhalation the pneumatic capacitor and pulmo nary modulator cycle to deliver high frequency typically 11 30 Hz pressure bursts to provide an effective intrapulmonary percussion treatment The high frequency pressure bursts are identical to those delivered by a high fre quency ventilator The bursts or boluses of gas serve to mobilize secretions by creating a gas bolus velocity profile that travels down the center of the bronchial airways Figure 1 This causes escaping or exhaled gas to travel at high speeds along the wall of the bronchial airways imparting a sizeable force on bronchial secretions moving them up and out of the airways The P NEB is designed to oscillate during inhalation for better aerosol deposition and during exhalation to help increase the speed of gas along the walls of the bronchial airways The pressure bursts also serve to intermittently squeeze the lymph _ g system within the lung increasing the flow rate at which fluids are processed through the l
31. ncy reduces coronary perfusion 5 2 4 acute abdominal distention 5 2 5 poor patient cooperation 5 2 6 pulmonary air leak Hazards 6 1 Effective therapy is accompanied by potential risks The thera pist must be sensitive to potential hazards that may be recog nized early and prevented IPV therapy should normally be discontinued when the patient has received the optimum thera peutic benefit or when the patient has become fatigued or has requested discontinuation Therapy must be discontinued if there is any equipment malfunction and the physician called immediately if any complications arise 6 2 Intrapulmonary percussive ventilation treatment will be immedi ately discontinued and the physician immediately contacted if the patient demonstrates any of but not limited to the follow ing adverse reactions 6 2 1 increased bronchospasm increased WOB SOB with therapy any sign of hypertension or hypotension any indication of pneumothorax any indication of allergic reaction to the medicine diluent or device component DAAH NNNN OBWN Page 7 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Protocol P NEB continued 6 3 6 4 6 5 6 increased HR gt 20 beats min from baseline value 7 decreased SpO lt 92 or increasing Fl O requirement with therapy 6 2 8 nausea vomiting 6 2 9 increase in abdominal distention or discomfort 6 2 10any unexpected increase in hemoptysis 6 2 1lonset of
32. oss V Vartian H K Chang and A Zidulka Enhanced Tracheal Mucus Clearance with High Frequency Chest Wall Compression American Review of Respiratory Diseases 1983 128 511 515 2 Castile R Tice J Flucke R Filbrun D Varekojis S and McCoy K Comparison of Three Sputum Clearance Methods in In patients with Cystic Fibrosis abstract 443 presented in 20th Annual North American Cystic Fibrosis Conference PercussiveTech HF is a trademark of VORTRAN Medical Technology 1 Inc Percussionaire and IPV are registered trademarks of PERCUSSIONAIRE CORPORATION Page 23 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VIII Coding information HCPCS HCFA Health Care Financing Administration Common Procedure Coding System PRODUCT PercussiveNEB and Hi Flow 70 Compressor CODE E0481 DESCRIPTION Intrapulmonary percussive ventilation system and related accessories INSTRUCTIONS The SADMERC and the four Durable Medical Equipment Regional Carriers DMERCs have completed the HCPCS Coding Verification Review on August 21 2002 The PercussiveNEB and Hi Flow 70 Compressor meets the characteristics and description of the HCPCS code as assigned for Medicare billing CMS CENTERS FOR MEDICARE amp MEDICAID SERVICES CPT Current Procedure Terminology American Medical Association PRODUCT PercussiveNEB CODE 94667 DESCRIPTION
33. percussine effects For best results start at SOFT setting and gradually increase to HARD setting to accommodate patient s needs and breathing pattern NOTE Positive End Expiratory Pressure PEEP is intrinsic to this device Baseline pressure can reach up to 8 cm H O ADJ UST AMPLITUDE VIEW T 6 8 Assessing Therapeutic Benefit 6 8 1 Increased secretion mobilization 6 8 2 Decreased WOB following therapy 6 8 3 Decreased bronchospasm 6 8 4 Increased inspiratory capacity 6 9 Documentation 6 9 1 Airway clearance therapy will be documented in the appropriate area i e Golden Rod or Phamis charting system and will in clude the following 6 9 1 1 Patient name account 6 9 1 2 Date time of Rx 6 9 1 3 Therapeutic objectives tolerance benefits and ad verse reaction to therapy 4 Medication diluent delivered 5 Type of therapy device 6 HR RR and B S before during and after 7 Cough evaluation secretion clearance amount color consistency 6 9 1 8 RCP name 6 9 2 Billing billing will be done according to standard regional car diopulmonary billing procedures for airway clearance therapy Page 10 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Illi Protocol P NEB continued 6 10 Cleaning 6 10 1 The PercussiveNEB is intended to be used on a single patient only 6 10 2 To disassemble 6 10 2 1 6 10 2 2 6 10 2 3 6 10 2 4 6 10 2 5 NOTE
34. r for cardiac surgery A well known complication of cardiac surgery is post operative atelectasis The traditional bronchial hygiene therapy approach to post operative atelectasis includes intermittent positive pressure breathing IPPB treatments followed by chest physiotherapy CPT Traditional therapy is extremely labor intensive and has in our experience demonstrated marginal clinical efficacy Moreover the traditional bronchial approaches to post operative atelectasis are inconsistent with our evidence based practice model Therefore a pilot study was conducted utilizing a disposable single patient use percussive nebulizer PN METHOD 26 post operative cardiac surgery patients who met our treatment criteria for post operative atelectasis were placed on PN therapy and evaluated Our treatment criteria for both groups included increasing fiO requirements ABG demonstrating hypoxemia and or hypercarbia with or without acidosis and chest x rays CXR showing atelectasis or infiltrates Clinical improvement was defined as clearing or improved CXR and a decreasing fiO requirement with an average fiO of 25 and SpO of 96 RESULTS All 26 patients in the PN group presented with atelectasis on CXR and were receiving high levels supplemen tal oxygen with an average fiO of 60 pre PN therapy Of these patients 24 showed clinical improvement in an average of 3 days There were two PN treatment failures one due to late intervention and another due to c
35. re flow No Compressors designed for small volume nebulizer treatments are not capable of deliver ing the needed flow Most hospital equipment rental agencies rent compressors large enough to power a ventilator This is needed for the PercussiveNEB You will also probably want to equip the compressor with a flow meter Page 14 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VI FAQ continued Question Answer 7 How much and what A physician must prescribe the type of medica kinds of medication do place in the nebu lizer How do I get 20 ml of fluid in the nebulizer After a 20 minute treatment still have liquid in the nebulizer reservoir If the nebulizer has an output rate of 1 ml min shouldn t all the liquid be gone What is re usable in PercussiveNEB 10 How long will my PercussiveNEB last tion and the amount for each treatment Com monly used medications are Beta agonists anticholinergics and mucolytics To mix the medication first place the prescribed amount of medication into the nebulizer reservoir Then add saline or respiratory quality water to make a total volume of 20 mL The nebulizer has an output of 1 mL min during inhalation when the patient is actually receiving aerosol During exhalation the output of the nebulizer is less so it is normal to have liquid left over in the reservoir Actual outputs will vary with each patient It is important th
36. rformed Two other devices which were designed for hospital use also deliver nebulized medications via positive oscillating pressure the PercussiveNEB Vortran Sacramento Calif and intrapulmonary percussive ventilation IPV Percussionaire Sandpoint Idaho The PercussiveNEB has not been shown to be effective and its use remains limited IPV uses small rapid high flow bursts of air to help loosen secretions it has been studied17 18in patients with neuromuscular weakness and atelectasis Anecdotal reports have indicated that IPV is a useful adjunct in clearing atelectasis in patients with neuro muscular weakness IPV has also been evaluated19 in CF in comparison with the Flutter and CPT No differences were found suggesting that IPV is no less effective than other forms of airway clearance IPV was also well tolerated The largest study group consisted of 16 subjects limiting to some degree the usefulness of this work Despite these promising reports from the mid 1990s no larger follow up studies have been published Jonathan Finder MD is associate professor of pediatrics University of Pittsburgh Page 17 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide VII Clinical Reference continued PercussiveNEB P NEB COST COMPARISON P NEB P D amp P Flutter with Aerosol with Aerosol TX with Aerosol TX Therapy time 15 minutes 45 minutes 30 minutes Cost for therapist 30 00 hour 30 0
37. ry weights were measured Nine participants completed the study No PFT param eters were significantly changed after CPT or PTHF although there was a trend to decreasing RV after both therapies There was a trend for more sputum production after PTHF compared to CPT mean wet weight 13 72 gm vs 7 75 gm and dry weight 1 47 gm vs 0 51 gm but this did not reach statistical significance There were no adverse events during or after either therapy except for minor hemoptysis in one patient after CPT Eight patients found the PTHF easy to use and six would prefer it over CPT Douglas N Homnick M D M P H Fred White R R T and Carol de Castro B S R N Comparison of Effects of an Intrapulmonary Percussive Ventilator to Standard Aerosol and Chest Physiotherapy in Treatment of Cystic Fibrosis Pediatric Pulmonary 1995 20 50 55 Summary Impaired mucociliary clearance due to defective ion and water transport and the effects of chronic airway infections lead to stasis of secretions and progressive pulmonary damage in patients with cystic fibrosis CF Methods to improve removal of tenacious lung secretions in CF patients contribute to slowing the decline in respiratory function We have evaluated an intrapulmonary percussive ventilator IPV which is a device designed to enhance airway clearance and preserve lung function A previous pilot study by us had determined that the device was acceptable to patients and is safe We undertook a 6 month
38. ut concentration of aerosol produced by both devices were measured to determine their operational characteristics Pressure waveforms were recorded to demonstrate the peak airway pressure and oscillation frequency for both devices under simulated breathing conditions METHOD Aerosol output and particle size were tested by setting up a lung simulator with a compliance of 0 02 L cm H O a resistance of 20 cm H O L sec and a simulated inhalation flow of 25 L min Three inhalation solutions normal saline 0 9 albuterol sulfate 2 5 mg and metaproterenol sulfate 10 mg were selected for testing The devices were run at two pressure settings 20 and 35 PSIG for a total of 15 minutes to simulate one treatment Inhalation aerosol was sampled with a cascade impactor at 1 4 L min for 2 minutes at the beginning and end of the treatment for each test The sample from the cascade impactor was used to determine the amount of drug delivered and the particle size distributed in MMAD mm and GSD s_ Pressure waveforms were recorded using a computer pressure and flow data acquisition system The patient simulator was set to a breathing rate of approximately 8 breaths per minute B P M with an I E ratio of approximately 1 1 Inspiratory and expiratory flow ranged up to 50 L min RESULTS The estimated aerosol output delivered to the patient was essentially identical for both devices as measured under the simulated breathing conditions I E ratio of 1 1 The actu
39. ymph sys tem Figure 1 Airway Clearing Technique lion me without High Frequency oe with High Frequency Page 2 VORTRAN Medical Technology 1 Inc Rev 3 5 2008 P NEB User s Guide Functional and Operational Characteristics Suitable patient body weight Greater than 10 kg Typical percussive oscillation frequency Up to 30 Hz 1800 per minute Device TOW 3 aces leet nee pega bees 43 to 73 L min Fractional inspired Oxygen FiO Greater than 80 when supplied with 100 O Operating environmental limits 5 to 40 C Storage environmental limits 20 to 60 C Patient CONNECTION eeeeee eee eee ee es Mouthpiece Gas Nlet naroa eaa abn ee YRS DISS connection Nebulizer reservoir SiZ 0 c0ceeeeeee 20 mL Approximate dimensions 006 10 x 8 x 3 5 Approximate weight eeeeeeeee es About 190 grams Clinical Considerations The P NEB is intended to be used only on those patients who are able to breathe spontaneously The P NEB is intended to be used with the attached mouthpiece If a corrugated tube is connected between the mouthpiece and the patient the pressure bursts received by the patient would be much weaker and dramatically less effective The P NEB requires some coordination and training On inhalation the pa tient should be encouraged to inhale as deeply as possible On exhalation the
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