Cystic Fibrosis

Cystic fibrosis (CF) is an inherited disorder characterized by abnormalities in mucus secretion and clearance. Secretions accumulated in the airways harbor infectious organisms and initiate a cascade of events leading to a vicious cycle of progressive lung disease, respiratory failure and ultimately, death. Lifelong daily airway clearance therapy is universally prescribed as medically necessary for all CF patients.



  1. Anbar RD. Compliance with use of ThAIRapy® Vest by patients with cystic fibrosis. Pediatr Pulmonol 1998; (suppl 17):346, A497.
    
Eighty-two patients using high frequency chest wall oscillation (HFCWO) for more than six months were evaluated retrospectively for compliance. Analysis of data recorded by a meter installed in the device showed fairly constant compliance over the first several months of therapy.
  2. Anbar RD, Powell KN, Iannuzzi DM. Short-term effect of ThAIRapy® Vest on pulmonary function of cystic fibrosis patients. Am J Respir Crit Care Med 1998; 157(suppl 3):A130.
    
A retrospective chart review of 54 cystic fibrosis patients receiving daily high frequency chest wall oscillation (HFCWO) therapy showed an aggregate average FEV1 improvement of 8% when compared with their best pulmonary function test (PFT) results obtained 0-6 months prior to initiation of HFCWO. Patients receiving regular CPT prior to initiation of HFCWO therapy (61%) showed FEV1 improvements averaging 7% compared to average improvements of 11% for patients receiving no regular pre-HFCWO airway clearance therapy (39%).
  3. Anbar RD. Use of ThAIRapy Vest does not affect liver function of patients with cystic fibrosis. Am J Respir Crit Care Med 1999; 159(3), A687.
    
A retrospective chart review of liver enzyme levels for 77 consecutive patients receiving short-term high frequency chest wall oscillation (HFCWO) therapy showed no evidence of an adverse effect on liver function.
  4. App EM, Lohse P, Matthys H, King M. Physiotherapy and mechanical breakdown of the excessive DNA load in CF sputum-an anti-inflammatory therapeutic strategy. Pediatr Pulmonol 1998; (suppl 17):349, A507.
    
Results of this study evaluating the effects of high-frequency oscillations on the breakdown of high-molecular-weight DNA in cystic fibrosis (CF) sputum samples suggest that such oscillations can break down DNA as effectively as rhDNAse treatments. Reductions in intact DNA are estimated at approximately 15% after 30 minutes of treatment.
  5. Arens R, Gozal D, Omlin KJ, Vega J, Boyd KP, Keens TG, Woo MS. Comparison of high-frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis. Am J Respir Crit Care Med 1994; 150:1154-1157.

    Fifty CF patients hospitalized for acute pulmonary exacerbation were randomly assigned to therapy with either HFCC or CPT three times daily. Clinical status and pulmonary function tests (PFT) were similar for both groups at admission. After 7 and 14 days of treatment with either intervention, both groups showed significant but similar improvements in clinical status and PFT scores and comparable time to discharge. HFCC and professionally administered CPT are judged equally safe and effective for secretion management during acute pulmonary exacerbations in CF patients.
  6. Braggion C, Cappelletti LM, Cornacchia M, Zanolla L, Mastella G. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study. Pediatr Pulmonol 1995; 19:16-22.
    
This randomized cross-over trial compared the short-term efficacy of three physiotherapy modalities – postural drainage (PD), positive expiratory pressure (PEP) therapy, and high frequency chest compression (HFCC)/high frequency chest  wall oscillation (HFCWO) – in 16 cystic fibrosis patients hospitalized for acute exacerbation. Subjects received a control session and randomized 2-day trials of each study modality. Results of sputum volume assays (wet and dry weight) and lung function scores (FEV1, FVC, and FEF) were similar for all three regimens.
  7. Burnett M, Takis C, Hoffmeyer B, Patil S, Pichurko B. Comparative efficacy of manual chest physiotherapy and a high-frequency chest compression vest in inpatient treatment of cystic fibrosis. Am Rev Respir Dis 1993; (suppl 147):A30.
    
This randomized controlled trial compared chest physiotherapy (CPT) and high frequency chest compression (HFCC) in 10 adult CF patients hospitalized for infectious exacerbations. Patients were randomized to receive alternate treatments of CPT for 30 minutes every 4 hours for 1 day or HFCC for 30 minutes every 4 hours for 1 day over 24 hours; treatments were administered for 4 to 8 days. HFCC data showed significantly greater secretion clearance (p = 0.04).
  8. Butler S, O’Neill B. High-frequency chest compression therapy: a case study. Pediatr Pulmonol 1995; 19:56-59.
    
A retrospective chart review of a patient with advanced cystic fibrosis lung disease showed improved clinical stability and reduced health care utilization after one year of high frequency chest compression (HFCC) therapy.
  9. Castile R, Tice J, Flucke R, Filbrun D, Varekojis, McCoy K. Comparison of three sputum clearance methods in in-patients with cystic fibrosis. Pediatr Pulmonol 1998; (suppl 17):329, A443
    .
Sputum production was measured and compared in 24 in-patients with cystic fibrosis (CF) receiving, in random order, 2 days each of manual chest physiotherapy (mCPT), intrapulmonary percussive ventilation (IPV), and high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) 3 times daily for 30 minutes. Wet and dry sputum weights were similar for all modalities except for wet weights derived from IPV; the difference is attributed to use of an aerosol mouthpiece that stimulates salivation.
  10. Clayton Sr RG, Donahue M. ThAIRapy use in 6 to 12 year old children with cystic fibrosis. Pediatr Pulmonol 1998; (suppl 17): 345, A496.
    
This retrospective review of medical records of 40 children with cystic fibrosis (CF) assessed lung function before and after initiation of high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) therapy. After one year of HFCC/HFCWO therapy, declining trends in FEV1 tended to stabilize or improve. HFCC/HFCWO treatment adherence as documented by a device use meter was 68.1% over a 22-month period.
  11. D’Angelo S, Craigmyle L, Kanga J. How are patients using alternating pressure vests for chest physiotherapy? Pediatr Pulmonol 1994; (suppl 10):266, A314.
    
This assessment of high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) use by 27 cystic fibrosis patients determined that 58% used their machines one hour or less per week. Most patients’ average daily use was consistent during the first three months of treatment, suggesting that early use habits are a strong predictor of future compliance.
  12. Darbee JC, Kanga JF, Ohtake PJ. Physiologic evidence for high-frequency chest wall oscillation and positive expiratory pressure breathing in hospitalized subjects with cystic fibrosis. Physical Therapy 2005; 85:1278-1289.
    
This study compared physiologic responses to two airway clearance techniques – high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) and low positive expiratory pressure (PEP) techniques – in hospitalized subjects with moderate to severe cystic fibrosis (CF) lung disease. Subjects were randomized to either HFCC/HFCWO or PEP on day one and the alternate therapy on day two. Data analysis showed that HFCC/HFCWO and PEP were equally efficacious in improving ventilation distribution, gas mixing, and pulmonary function.
  13. Dosman CF, Zuberbuhler PC, Tabak JI, Jones RL. Effects of positive end-expiratory pressure on oscillated volume during high frequency chest compression in children with cystic fibrosis. Can Respir J. 2003; 10:94-98.

    In a clinic-based prospective study of 9 children with minimal cystic fibrosis (CF) obstructive airway disease, positive end-expiratory pressure (PEEP) was combined with high-frequency chest compression (HFCC) to evaluate possible additive therapeutic effect. Subjects were placed in a closed – circuit spirometry system and evaluated for changes in end-expiratory lung volumes (EELV) and mean oscillated volume (Vosc) during HFCC alone, and then during HFCC+PEEP. Data showed that adding PEEP during HFCC prevents an HFCC-associated drop in EELV and increases Vosc, suggesting that the addition of PEEP may improve HFCC-induced mucus clearance in children with CF.
  14. Grece CA. Effectiveness of high frequency chest compression: a three-year retrospective study. Pediatr Pulmonol 2000; (suppl 20):452.
    
This three-year retrospective study of 41 cystic fibrosis (CF) patients using either manual chest physiotherapy (CPT) or high-frequency chest compression (HFCC) found a significant improvement in weight gain in the HFCC group (p=0.0001), but no significant differences in hospitalization days or pulmonary function between the two groups.
  15. Hansen L, Warwick W. High-frequency chest compression system to aid in clearance of mucus from the lung. Biomed Instrum Technol 1990; 24:289-294.
    
In a crossover study comparing the volume of mucus cleared using HFCC vs CPT, 5 cystic fibrosis (CF) patients received 30 time and day-matched sessions of each modality administered by a professional therapist. Data showed 1) increased mucus clearance [3.3cc/ HFCC therapy session vs 1.8 cc/ chest physiotherapy (CPT) session] and; 2) Improved lung function. The paper also includes an outcomes report of a 60-month retrospective/prospective study of HFCC use in a 48 year-old man with CF and Pseudomonas aeruginosa in his sputum and a two-year history of worsening pulmonary function. Results showed: 1) after one year of HFCC, the patient’s pulmonary function returned to the level measured five years before initiation of HFCC therapy; 2) a baseline technetium aerosol scan showed absence of ventilation in the upper lobes, but after 8 months of HFCC, a repeat test showed that ventilation was restored in these regions. For every outcome measure, HFCC therapy was shown to be more effective than standard chest physical therapy.
  16. Hull KK, Warren RH. ThAIRapy Vest vs. conventional chest physical therapy (CPT): case report. Respir Care 1991; 36:1266-1267.
    
This case report describes the effects of high frequency chest compression (HFCC) therapy in a 32 year old man hospitalized with end-stage cystic fibrosis (CF) lung disease. Chest physiotherapy was administered for 26 in-patient days with no appreciable mobilization of secretions. CPT was replaced with HFCC for 30 minutes 4x daily, resulting in copious mucus production and improved pulmonary function (FEV1: pre- admission = 0.59; day 27 = 0.70; day 30 = 0.87). After 4 days of HFCC therapy, the patient felt well enough to be discharged.
  17. Jones RL, Lester RT, Brown NE. Effects of high-frequency chest compression on respiratory system mechanics in normal subjects and cystic fibrosis patients. Can Respir J 1995; 2:40-46.
    
In this randomized blinded study investigating short-term effects of high frequency chest compression (HFCC) on several indices of respiratory system mechanics, 10 normal and 10 stable cystic fibrosis (CF) volunteers received HFCC at 10 randomized settings (5, 10, 15, 20, 25 Hz; highest and lowest pressures); effects were measured with balloon-tipped esophageal catheters, spirograms and reverse plesmography. Both normal and CF subjects had similar changes in esophageal pressure (Pes) and end-expiratory lung volume (EELV). EELV decreased approximately 30% from the no-HFCC baseline functional residual capacity (FRC). Differences between normals and CF subjects were dependent upon overall airway function. In CF patients with moderate to severe airway obstruction, HFCC at low pressure and 10-15 Hz minimizes decrease in EELV and maximizes oscillatory flow.
  18. Kempainen R, Hazelwood A, Williams C, Dunitz J, Billings J, Milla C. Comparison of airway clearance efficacy of sine and triangular wave high frequency chest wall oscillation in patients with cystic fibrosis. Poster Presentation. North American Cystic Fibrosis Conference, Denver, Co Nov 2-5, 2006.
    
Fifteen stable CF patients were randomly allocated to receive one 30-minute treatment with each of two high frequency chest wall oscillation (HFCWO) machines [The Vest® airway clearance system model 104 (Hill-Rom, St. Paul MN) and the inCourage® System,  (RespirTech, St. Paul MN)]. A two-day washout interval separated sessions; double-blinding was attempted. Outcomes for: 1) sputum production were non significantly but quantitatively greater with the inCourage System; 2) pulmonary functions were statistically significantly better with the inCourage System for residual lung volumes (suggesting less air-trapping) and forced expiratory volume (FEV) (suggesting greater ability to generate a mucus-clearing cough); 3) differences in mucus rheology (viscosity, elasticity, etc.) were statistically non-significant but numerically better for the inCourage System; 4) mucus cough transportability was statistically significantly better for the inCourage System and 5) comfort ratings were equal and positive. 
  19. Kluft J, Beker L, Castagnino M, Gaiser J, Chaney H, Fink R. A comparison of bronchial drainage treatments in cystic fibrosis. Pediatr Pulmonol 1996; 22:271-274.
    
This large randomized controlled crossover trial compared the square waveform model 102™ HFCWO device [Advanced Respiratory, Inc., St. Paul, MN] with professionally administered chest physiotherapy (CPT) in 29 cystic fibrosis (CF) patients hospitalized with acute pulmonary exacerbations. Subjects were allocated to treatment with HFCWO and CPT for 2 days each over a 4-day period. Sputum weight, both wet and dry, was used as a clinical index of mucus clearance efficacy. Results showed significantly greater volume for volume clearance in the HFCWO group compared to the CPT group; (wet: p = 0.001; dry: p = 0.01).
  20. McColley SA, Harris CV, Qualter N, O’Malley C, Boas SR, Jain M. Predictors of adherence to an airway clearance technique in cystic fibrosis. Pediatr Pulmonol 1999; (suppl 19):332, A582.
    
This study was designed to assess treatment adherence (TA) with high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) therapy and to identify predictors of TA. Participants included twenty-eight cystic fibrosis (CF) patients aged 7-23. Usage times recorded for six months with an hour meter installed in the HFCC/HFCWO machine showed TA to be 43±27%. Factors associated with better TA include 1) greater age; 2) poorer nutrition; 3) worse pulmonary function and; 4) more positive self-assessment of quality of life.
  21. McColley SA, Schulz C, Qualter N, Boas SR, Jain M, Goodman DM. Participation in an observational study of airway clearance in cystic fibrosis does not influence patient adherence. Pediatr Pulmonol 1999; (suppl 19): 331, A581.

    In this corporate-sponsored assessment of treatment adherence (TA) with a high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) machine, young ( ages 9-23) cystic fibrosis patients with mild to moderate disease were enrolled in the manufacturer’s outcomes monitoring program. Data showed that HFCC/HFCWO TA was 48±28% for study participants and 49±30% for age-matched patients also receiving the corporate outcomes monitoring but not enrolled in the formal study, suggesting that knowledge of participation in a study does not affect compliance behavior.
  22. Milla CE, Hansen LG, Warwick WJ. Different frequencies should be prescribed for different high frequency chest compression machines. Biomed Instrum Technol 2006; 40 (4): 319-324.
    
HFCC treatment frequencies may be prescribed according to the manufacturers’ generic guidelines or may be determined for each individual patient by a “tuning” method that measures, at the mouth, the air volume displacement and the associated airflows produced at each frequency. This paper describes a protocol for finding the best frequencies and pressures for individual patients based upon a sample of 100 consecutive tunings. Data showed that every frequency from 6 and 20 Hz was a best frequency for at least one patient.
  23. Milla CE, Hansen LG, Weber A, Warwick WJ. High-frequency chest compression: effect of the third generation compression waveform. Biomed Instrum Technol. 2004; 38:322-328.

    In a study comparing the differences in output characteristics between triangle waveform and sine waveform HFCC machines, eight stable CF subjects treated with both modalities yielded a 20% mean increase in volumes of mucus cleared – with a range of improvement up to 41% – with the triangle waveform machine. Authors speculate that 1) the shape of the waveform delivered by HFCC machines is important in maximizing mucus clearance; 2) the triangle waveform may be more effective because peak airflow and maximum lung volumes occur at the same frequencies and; 3) the triangle waveform may be more comfortable as a result of the shorter duration of peak pressure and venting to atmospheric pressure.
  24. Oermann CM, Sockrider MM, Giles D, Sontag MK, Accurso FJ, Castile RG. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: A pilot study. Pediatr Pulmonol 2001; 32:372-377.
    
This prospective, randomized, multicenter crossover pilot study evaluates the efficacy and patient satisfaction with high frequency chest wall oscillation (HFCWO) and oscillating positive expiratory pressure (OPEP) compared to percussion and postural drainage (PDPV) in the home use setting. Twenty-nine CF patients, 9-39 years of age, performed 4 weeks each of HFCWO and OPEP following 2-week lead-in/washout periods. Efficacy, safety and compliance differences among therapies were non-significant, but given a choice of therapy, 50% of subjects chose HFCWO, 37% OPEP, and 13% PDPV.
  25. Oermann CM, Swank PR, Sockrider MM. Validation of an instrument measuring patient satisfaction with Chest Physiotherapy (CPT) techniques in cystic fibrosis. Chest 2000; 
118:92-97.
    
A validated survey instrument to assess patient satisfaction with three airway clearance techniques showed that users of a high frequency chest compression (HFCC)/high frequency chest wall oscillation (HFCWO) device reported the highest levels of overall satisfaction ( p = < 0.0001) and perceived it as more efficacious ( p = 0.045) when compared to either CPT or the Flutter® valve [post-test Tukey’s Honestly Significant Difference (HSD) method]. Treatment adherence is strongly correlated to severity of illness.
  26. Oermann CM, Accurso F, Castile R, Sockrider MM. Evaluation of the safety, efficacy and impact on quality of life of the ThAIRapy Vest and Flutter® compared to conventional chest physical therapy (CPT) in patients with cystic fibrosis. Am J Respir Crit Care Med 1997; 155(suppl 4): A638.

    This multicenter, randomized crossover study compared efficacy, safety and patient satisfaction of three popular airway clearance modalities (CPT, HFCC/HFCWO and Flutter). Twenty-four CF patients completing the study received two cycles of a 2-week standard CPT lead-in period followed by 4 weeks of either HFCC/HFCWO or Flutter treatments. Spirometry, lung volumes, NIH and Petty scores, and a satisfaction survey were performed at baseline and after each treatment period. Results showed comparable safety and efficacy for all three modalities, but with NIH scores improved from baseline with HFCC/HFCWO (p= .04); subjects expressed a clear preference for HFCC over both CPT and Flutter.
  27. Phillips GE, Pike SE, Jaffe A, Bush A. Comparison of active cycle of breathing and high-frequency oscillation jacket in children with cystic fibrosis. Pediatr Pulmonol. 2004; 37:71-75.

    In this study of secretion clearance performance comparing active cycle of breathing techniques (ACBT) with high frequency chest compression ( HFCC)/high frequency chest wall oscillation (HFCWO) administered by the Hayek Oscillator Cuirass, ten children experiencing CF pulmonary exacerbations received either two supervised sessions using HFCC/HFCWO or two self-treatment ACBT sessions in random order on successive days. Sputum weight and pulmonary function increased significantly with ACBT compared with HFCC/HFCWO, suggesting that ACBT may be more effective for airway clearance during infective CF exacerbations than the Hayek Cuirass.
  28. Robinson C, Hernried L. Evaluation of a high frequency chest compression device in cystic fibrosis. Pediatr Pulmonol 1992; (suppl 8):304, A255.
    
A three month assessment of the effects of high frequency chest compression (HFCC) on pulmonary function scores showed neither significant improvement nor deterioration; participants reported greater independence and improved ability to self-manage their disease with HFCC.
  29. Scherer TA, Barandun J, Martinez E, Wanner A, Rubin EM. Effect of high-frequency oral airway and chest wall oscillation and conventional chest physical therapy on expectoration in patients with stable cystic fibrosis. Chest 1998; 113:1019-1027.
    
This prospective randomized short-term study compares the effects of oral high-frequency (OHFO) airway oscillation, high frequency chest wall oscillation (HFCWO), and chest physiotherapy (CPT) in 14 CF patients over age 12 with stable disease. Each subject received two modes of OHFO (1) frequency 8 Hz; inspiratory to expiratory [I:E] ratio 9:1; 2) frequency 14 Hz; I:E ratio 8:1); two modes of HFCC (1) frequency 3 Hz; I:E ratio 4:1; 2) frequency 16 Hz; I:E ratio 1:1, alternating with frequency 1.5 Hz, I:E ratio 6:1), and CPT (clapping, vibration, postural drainage, and encouraged coughing). Subjects had one treatment per study day with 2 or more days between study days. Data were comparable for each modality with respect to weight of expectorated sputum, pulmonary function scores, and oxygen saturation values. All treatments were tolerated but some patients expressed discomfort with oral high-frequency oscillation.
  30. Tecklin JS, Clayton RG, Scanlin TF. High frequency chest wall oscillation vs. traditional chest physical therapy in CF-a large, one-year, controlled study. Pediatr Pulmonol 2000; (suppl 20):459.
    
This well-powered one-year retrospective chart review comparing pulmonary function test (PFT) scores and chest x-ray interpretations in cystic fibrosis patients receiving either high frequency chest wall oscillation (HFCWO) therapy or chest physiotherapy (CPT) showed comparable PFTs; Brasefield chest x-ray scores were statistically significantly better with HFCWO.
  31. Varekojis SM, Douce FH, Flucke RL, Filburn DA, Tice JS, McCoy KS, Castile RG. A comparison of the therapeutic effectiveness and preference for postural drainage and percussion, intrapulmonary percussive ventilation, and high-frequency chest wall compression in hospitalized cystic fibrosis patients. Respir Care 2003; 48:24-28.
    
This comparison study of three airway clearance methods including 1) postural drainage and percussion (PD&P); 2) intrapulmonary percussive ventilation (IPV) and; 3) high frequency chest compression (HFCC)/high frequency chest  wall oscillation (HFCWO), assigned 24 hospitalized CF patients ( aged 12 or older) in random order 2 consecutive days of each therapy, delivered 3 times daily for 30 minutes. Sputum was collected during and for 15 minutes after each treatment and assayed for wet and dry weights. The mean wet sputum weights differed significantly (p = 0.035), with wet sputum weights from IPV significantly greater than with HFCC/HFCWO (p < 0.05). All three modalities are judged comparably effective and equally accepted by patients.
  32. Warwick WJ, Hansen LG. The long-term effect of high-frequency chest compression therapy on pulmonary complications of cystic fibrosis. Pediatr Pulmonol 1991; 11:265-271.

    This four-year retrospective study of CF patients compared pulmonary function after two years of chest physiotherapy treatment CPT followed by two additional years of high frequency chest compression (HFCC) therapy. After two years of HFCC, 94% of subjects-regardless of disease severity or age- showed either a slowing or reversal of the decline experienced during CPT treatment in terms of percent FEV1; most of the subjects showed meaningful clinical improvement. Results are unprecedented.
  33. Warwick WJ, Wielinski CL, Hansen LG. Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression. Biomed Instrum Technol. 2004; 38:470-475.
    
This study compared wet and dry weights of sputum produced by 12 subjects with cystic fibrosis (CF) who received high-frequency chest compression (HFCC) and professionally administered standard chest physical therapy (CPT) in randomized order. The wet and dry weights of the sputum produced as a result of the two techniques were significantly different, with HFCC having greater weight. Regardless of the mode of therapy, the sputum produced by the subjects who regularly received HFCC (6 subjects) had greater water content than did the sputum produced by those subjects who regularly received CPT (6 subjects).
  34. Wielinski CL, Warwick WJ. Change in pulmonary function over a 30-month period for high-frequency vest users vs. non-users in a cystic fibrosis population. Am J Respir Crit Care Med 1996; 153:A71.
    
In a 30 month study to assess long-term effects of high frequency chest compression (HFCC) on pulmonary function, test results of 140 cystic fibrosis patients treated with HFCC were compared with 79 who were not exposed to HFCC. Baseline measures were similar for both groups. Over 30 months, decline in % predicted forced expiratory flow at 25-75% (FEF 25-75%) was less for the HFCC group (P = 0.04): HFCC males had significant improvement in forced expiratory volume at one second (FEV1) (p = <.0.05) and FEF 25-75% (P = < 0.01), confirming the long-term benefit of HFCC for preservation of pulmonary function.

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