(Chest. 2004;125:1507-1511.)
© 2004
American College of Chest Physicians
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
* From the Pediatric Pulmonary Division, Department of Pediatrics, Michigan State University, Kalamazoo Center for Medical Studies (Drs. Marks and Homnick, and Ms. Hare), and Pulmonary Function Laboratory, Bronson Methodist Hospital (Mr. Saunders), Kalamazoo, MI.
Correspondence to: John H. Marks, MD, FCCP, Department of Pediatrics, Michigan State University, Kalamazoo Center for Medical Studies, 1000 Oakland Dr, Kalamazoo, MI 49008; e-mail: marks{at}kcms.msu.edu
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Abstract
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Study objective: To compare the PercussiveTech HF (PTHF) device (Vortran Medical Technology 1; Sacramento, CA) to standard 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 quantitative 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 and effective method of airway clearance in CF patients in this small pilot study.
Key Words: chest physiotherapy • cystic fibrosis • intrapulmonary percussion • mucus clearance • pulmonary function
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Introduction
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Management of the pulmonary complications of cystic fibrosis (CF) involves chest physiotherapy to remove obstructing secretions from the airways, aerosol therapy with bronchodilators and mucolytics to dilate respiratory passages and break down secretions, and antibiotic therapy to control pulmonary infections.1 Manual chest physiotherapy (CPT) with gravity-assisted drainage continues to be the "gold standard" method of airway clearance for patients with CF.2 While CPT has long been shown to aid in clearance of pulmonary secretions in patients with CF, compliance in the daily regimens of therapy are often an issue due to time involved and the need for assistance in such therapy. Several independently administered airway clearance devices have been shown to be effective in aiding airway clearance in patients with CF, including positive expiratory pressure, the Flutter device (Axcan Pharma; Birmingham, AL), a high-frequency chest wall compression vest, and the intrapulmonary percussive ventilator (IPV). We have previously reported on the effectiveness of the IPV compared to CPT and the Flutter device in short-term pilot studies34 and in a 6-month parallel trial.5
This pilot study compares a relatively new device that aids in mucous clearance from airways, the PercussiveTech HF (PTHF) device (Vortran Medical Technology 1; Sacramento, CA), to CPT in patients with CF. The PTHF device (Fig 1
) delivers rapid, minibursts of air (intrapulmonary percussion) with high-volume aerosol delivery. The PTHF is a new and unique intrapulmonary percussive treatment device that incorporates a nebulizer, which delivers a large volume (15 to 20 mL) of aerosolized medication. The PTHF device is designed to oscillate primarily during exhalation providing intrapulmonary percussion at 6 to 14 Hz (360 to 840 oscillations per minute) for use in the removal of mucus from the lungs of patients with retained endobronchial secretions. The PTHF requires high gas flow (> 60 L/min) using a dedicated high-output compressor for outpatient use. The majority of the flow rate is used mainly to operate the internal components and is not delivered to the patient. A disassembled PTHF device is shown in Figure 2
. After filling the nebulizer reservoir, a compressed air source is attached and, with the mouthpiece occluded, flow is increased until the device begins to cycle. The mouthpiece is placed in the patient’s mouth, and flow is adjusted until the modulator piston is noted to be oscillating. Further flow adjustments are made to accommodate the patient’s comfort and breathing pattern. Minor changes in frequency and amplitude can result from adjustments in flow and patient breathing pattern. Proposed benefits of the PTHF included patient independence, time savings, ease and comfort of use, and better self-management of the disease process. We compared change in pulmonary function and sputum production following a single treatment with the PTHF with changes following a standard CPT treatment done by a respiratory therapist in stable outpatients with CF.
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Materials and Methods
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The study was approved by the Human Use Committee of Bronson Methodist Hospital. Informed consent was obtained from all participants and the parents/guardians of those patients < 18 years old.
Ten participants recruited from the Cystic Fibrosis Center at Michigan State University/Kalamazoo Center for Medical Studies had a diagnosis of CF confirmed by clinical history, physical examination, and sweat chloride level 
60 mEq/L and/or genetic testing. Patients were included if they were clinically stable (no treatment for a pulmonary exacerbation within 2 weeks), age 8 years old, able to perform pulmonary function tests (PFTs) and use the PTHF device, and had no history of pneumothorax or major hemoptysis within 1 year. Severity of CF was determined for each participant prior to the start of the study using the Shwachman-Kulczycki score.6
The study design was a single-intervention, randomized cross-over, open-label trial consisting of two treatments on different days 1 week apart. Participants went without breakfast and withheld their regular airway clearance and aerosol medications on both study days. On the first study day, participants were randomized to either treatment A: 2.5 mg of albuterol in 20 mL of normal saline solution delivered via the PTHF device with positive end-expiratory pressure up to 8 cm H2O and peak pressure of 20 cm H2O at an oscillation frequency of 6 to 14 Hz when operated with hospital wall outlet compressed air; or treatment B: 2.5 mg of albuterol in 3.0 mL of normal saline solution delivered via standard nebulizer, followed by CPT administered by a respiratory therapist according to CF Foundation Guidelines. Participants crossed over to the alternate treatment on study day 2. The first few treatments with the PTHF device took > 30 min when 20 mL of saline solution was used; therefore, saline solution volume was decreased to 15 mL in order to reduce treatment time to approximately 20 min. Standard aerosol and CPT treatments averaged 45 min. Mouth pressure vs time tracings were recorded in the PTHF treatment in two participants.
PFTs, including FVC, FEV1, FEV1/FVC ratio, mean forced expiratory flow during the middle half of vital capacity, total lung capacity (TLC), residual volume (RV), and RV/TLC ratio, was administered by a pulmonary function technician unaware of the treatment regimen assigned to each participant. The best of three FVC maneuvers was obtained and recorded for each participant. The same technician and American Thoracic Society-approved spirometer and plethysmograph (Jaeger; Wurzburg, Germany) were used for all PFT measures throughout the study. After pretreatment PFT measures were obtained, a second respiratory technician, experienced with both CPT as well as the PTHF device, administered the assigned treatment to each participant. Repeat PFT measures were obtained at 4 h after the initiation of treatment. On completion of each 4-h study day, participants were asked to resume their regularly prescribed home airway clearance regimens.
The PFT results were recorded as percentage of predicted values,78 and the differences between pretherapy and posttherapy values were compared. All expectorated sputum was collected over the initial 4 h after each treatment. During the first 4 h, salivary contamination was minimized by placing dental cotton dams in the mouth over the parotid duct before sputum expectoration.9 The quantity of sputum expectorated was determined by mass wet weight. Then the samples were dried in a standard laboratory drying oven (Lab-Line Instruments; Melrose Park, IL) to obtain dry weight and to determine the dry-to-wet weight ratio.
During the treatments (CPT or PTHF), participants were monitored for any adverse effects including hypoxemia by continuous pulse oximetry. After completion of both treatment days, participants were given a questionnaire regarding their impressions of and satisfaction with the PTHF device.
Standard paired and unpaired t tests were used to relate pretreatment and posttreatment PFT results within groups and to compare pretreatment and posttreatment PFT results and sputum volumes between groups. The level of significance was set at p < 0.05.
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Results
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Nine participants completed the study. Participant demographics are shown in Table 1
. One patient was excluded after having minor hemoptysis following CPT. All participants had mild-to-moderate disease severity. All tolerated both treatments with no significant oxyhemoglobin desaturation (data not shown). Mean pulmonary function and wet and dry sputum weight results are shown in Table 2
. No PFT parameters were significantly changed at 4 h 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, but this did not reach statistical significance. Individual subject pulmonary function and sputum data are shown in Table 3
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Table 3.. Percentage Change From Baseline Pulmonary Function and Sputum Production for Each Subject Following Each Treatment
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Mouth pressure-time recordings were obtained on two participants to assess the frequency and amplitude of the positive pressure oscillations during a PTHF treatment. The tracings are shown in Figure 3
. Questionnaire results demonstrated overall satisfaction with the PTHF device, with eight of nine participants finding it easy to use and six of nine preferring PTHF over CPT.
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Figure 3.. Mouth pressure and amplitude recording with PTHF device in two patients with CF. Top: Pressure recorded at the mouth shows oscillations at approximately 10 Hz with amplitude of 0 to 6 cm H2O during inhalation and 8 to 14 cm H2O during exhalation. Bottom: This patient has no oscillations during inhalation and lower pressure and frequency during exhalation than the above patient. Note that the pressure scale ranges from – 5 to + 35 mm Hg, and patient values have been converted to cm H2O.
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Discussion
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This is the first clinical study of the PTHF device compared to standard CPT. Although a small, single-intervention pilot study, we feel it demonstrates the short-term safety and efficacy of the PTHF device. We have previously studied the Flutter device and the IPV in patients with CF.345 These airway clearance devices utilize oscillating positive pressure delivered to the airway to enhance clearance of airway secretions. In two short-term studies, we found no difference in sputum production between standard CPT and the IPV34 or the Flutter device.3 Another study10 reported increased sputum production with the Flutter device compared to CPT. The current study found a trend toward more sputum production with the PTHF device compared to standard CPT. Sputum production, as assessed by wet weight, following PTHF treatment was similar to that reported by Konstan et al10 following Flutter therapy, although collection methods were different. Sputum production following PTHF treatment appears to be greater than that following IPV or Flutter treatments in our previous study.4 Although the same collection method was used, the two studies cannot be directly compared. The clinical value of sputum production following a single intervention therapy remains questionable.
The PTHF and IPV are similar devices, both delivering large-volume aerosol while delivering oral high-frequency positive pressure airway oscillation. The IPV is designed to oscillate primarily during inhalation with exhalation being passive. The PTHF device oscillates during both inhalation and exhalation, but is designed to cycle mainly during exhalation, maintaining airway patency. The mouth pressure tracings in Figure 3 demonstrate the different oscillation patterns that can be obtained in patients using the PTHF device. The IPV oscillates at 3 to 5 Hz, while the PTHF device oscillates at a higher frequency, 6 to 14 Hz, which is closer to normal ciliary beat frequency.11 Airway oscillations have been reported to alter mucus characteristics to enhance mucus clearability.12 Analysis of the physical properties of expectorated sputum in a previous study3 showed no meaningful differences between IPV and CPT treatments. We did not analyze physical properties of mucus expectorated by participants in the current study.
Many airway clearance methods have been studied and promoted as being effective alternatives to standard chest percussion and postural drainage. The greatest advantage of these methods is patient independence and possibly improved adherence. Directed cough, forced expiratory technique, and autogenic drainage do not require a device to perform. Methods requiring a device to perform range from inexpensive (Flutter and positive expiratory pressure mask, both < $50) to expensive, more complicated devices (IPV, > $3,000; high-frequency chest wall oscillation vest, > $15,000). The cost of the PTHF is approximately $1,000 for the home compressor and two PTHF nebulizers. Each single patient-disposable PTHF nebulizer should last 3 months with twice-daily use and intermittent cleaning. Replacements are approximately $50 each.
The PTHF device was well tolerated and accepted by patients with CF in this single intervention pilot study. No adverse effects were observed, and the PTHF device was as effective as standard CPT. A majority of patients preferred the PTHF treatment to standard CPT, which may improve patient adherence to long-term therapy. However, the current pilot study does not justify the cost of the PTHF device compared to less expensive airway clearance methods. Long-term studies of the effects of the PTHF device on pulmonary function will be needed before it can be recommended as an alternative to CPT or other airway clearance methods.
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Footnotes
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Abbreviations: CF = cystic fibrosis; CPT = manual chest physiotherapy; IPV = intrapulmonary percussive ventilator; PFT = pulmonary function test; PTHF = PercussiveTech HF; RV = residual volume; TLC = total lung capacity
Presented at the Thirteenth Annual North American Cystic Fibrosis Conference, Seattle, Washington, October, 1999.
Supported by a research grant from Vortran Medical Technology 1, Sacramento, CA.
Received for publication August 29, 2002.
Accepted for publication October 9, 2003.
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References
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- Wilmott, RW, Fiedler, MA (1994) Recent advances in the treatment of cystic fibrosis. Pediatr Clin North Am 41,431-451[ISI][Medline]
- Reisman, JJ, Rivington-Low, B, Corey, M Role of conventional physiotherapy in cystic fibrosis. J Pediatr 1988;113,632-666[CrossRef][ISI][Medline]
- Natale, JE, Pfeifle, J, Homnick, DN Comparison of intrapulmonary percussive ventilation and chest physiotherapy: a pilot study in patients with cystic fibrosis. Chest 1994;105,1789-1793[Abstract/Free Full Text]
- Newhouse, PA, White, F, Marks, JH, et al The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr 1998;37,427-432[Abstract/Free Full Text]
- Homnick, DN, White, F, de Castro, C Comparison of effects of an intrapulmonary percussive ventilator to standard aerosol and chest physiotherapy in treatment of cystic fibrosis. Pediatr Pulmonol 1995;20,50-55[ISI][Medline]
- Shwachman, H, Kulczycki, CL Long term study of one hundred patients with cystic fibrosis. Am J Dis Child 1958;96,6-15
- Polgar, G, Promadhat, V Pulmonary function testing in children: techniques and standards 1971 WB Saunders. Philadelphia, PA:
- Morris, JF, Koski, A, Johnson, LC Spirometric standards for healthy non-smoking adults. Am Rev Respir Dis 1958;103,57-67
- Puchelle, E, Tournien, JM, Zabim, JM, et al Rheology of sputum collected by a simple technique limiting salivary contamination. J Lab Clin Med 1984;103,347-353[ISI][Medline]
- Konstan, MW, Stern, RC, Doershuk, CF Efficacy of the flutter device for airway mucus clearance in patients with cystic fibrosis. J Pediatr 1994;124,689-693[CrossRef][ISI][Medline]
- Pavia, D, Agnew, JE, Lopez-Vidriero, MT, et al General review of tracheobronchial clearance. Eur J Respir Dis 1987;71(suppl 153),123-129
- App, EM, Kieselman, R, Reinhardt, D, et al Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs autogenic drainage. Chest 1998;114,171-177[Abstract/Free Full Text]
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Abstract
Introduction
