High Frequence Chest Wall Oscillation and Cystic Fibrosis study in the UK

Wow I feel so fortunate to have had HFCC available to me for a very low cost since 1997.....

High Frequence Chest Wall Oscillation and Cystic Fibrosis

This study is not yet open for participant recruitment.

Verified by Imperial College London, January 2010

Sponsor: Imperial College London

Collaborators: Royal Brompton & Harefield NHS Foundation TrustHill-Rom

Purpose : High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. These observations led to the development of The Vest® which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates The Vest®, which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs that are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of mucus and this should further enhance mucus clearance.

People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary exacerbation, should increase the frequency and duration of their airway clearance sessions owing to the increase in quantity and viscosity of purulent bronchial secretions.In the United Kingdom, and in many other countries, the availability of physiotherapists to assist with the recommended number of daily treatments is insufficient to meet patient need. If the use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance techniques, in the early morning and evening was to facilitate recovery from an exacerbation, this would indicate an important place for high frequency chest wall oscillation in the management of people with cystic fibrosis.

Hypothesis: The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy is as effective as the addition of self treatment in facilitating recovery from an acute infective pulmonary exacerbation, as measured by improvement in lung function, specifically forced expiratory volume in one second (FEV1).

Device: High Frequency Chest Wall Oscillation (HFCWO)

Other: Usual airway clearance

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:The Use of High Frequency Chest Wall Oscillation During an Acute Infective Pulmonary Exacerbation of Cystic Fibrosis

Primary Outcome Measures:
Mean percentage change in forced expiratory volume in one second (FEV1) [ Time Frame: 7days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Wet weight of sputum expectorated [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Length of time to next course of intravenous antibiotics [ Time Frame: Within 6 monthsof completing study ] [ Designated as safety issue: Yes ]
Rate of change of C-reactive protein [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56

Study Start Date: February 2010

Estimated Study Completion Date: July 2011

Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Usual Airway Clearance Technique: Active Comparator

Two self administered treatment sessions a day and two treatments a day assisted by a Physiotherapist both using the patient's usual airway clearance method.

Other: Usual airway clearance
Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure

High Frequency Chest Wall Oscillation (HFCWO): Experimental
Two self administered treatments a day using HFCWO and two treatment sessions a day assisted by a Physiotherapist using their 'usual' airway clearance method.

Device: High Frequency Chest Wall Oscillation (HFCWO)
Airway clearance using the high frequency chest wall oscillator device

Contacts
Contact: Elizabeth A Banks, MSc
0207 351 8935
e.banks@imperial.ac.uk
Contact: Penny Agent
0207 352 8121 ext 8056

Locations

United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom

Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Hill-Rom

Investigators

Principal Investigator:
Margaret Hodson
Imperial College London

Vest studies

Always a debate as to whether CPT or the Vest is better.

First off I will say I firmly believe that European/Canadian/Australian governments don't discuss or offer the Vest because they have socialized medicine and don't wish to pay for it. It's sad and I think it partly contributes to lower median survival rates verus the US.

Secondly, one thing that makes the Vest adventageous is that it is done the same way, consistently, every time. When you have a human performing manual CPT, there is always variation - no two sessions are the same.

Finally, you're never dependent on someone else. I bet everyone who does manual CPT has missed a sessiond to do another person not having time/wanting to/whatever reason being able to do the session for the CFer. You never have that with the Vest (unless you're in Europe with your American Vest and you didn't bring your transformer).

You have one life. One set a lungs. If there's a possibility to slighly imrove your lung function and possibly add years of quality and/or quantity of life, the choice is a no-brainer to me.

Here are a few studies measuring mucus clearance of CPT versus the Vest:



http://www.respirtech.com/pdfs/Hansen.pdf


In a crossover study comparing the volume of mucus cleared using HFCC vs. CPT,
HFCC therapy was shown to be more effective than standard CPT for all outcomes
measured.

Title: Hansen LG, Warwick WJ. High-frequency chest compression system to aid in
clearance of mucus from the lungs. Biomed Instrum Technol 1990;
July/August: 289-294.

Design: Crossover

Method: 5 CF patients received 30 HFCC and 30 professionally administered CPT
sessions.

• Sessions matched for time of day
• Session durations uniform (unspecified)
• Total volume of expectorated sputum collected
• Mean volume with each modality compared
• PFTs compared

Results: Compared to 30 CPT treatments, 30 HFCC treatments showed:

• Significantly more mucus clearance with HFCC (3.3cc/HFCC session
vs. 1.8 cc/ CPT session [p<0.001])
• Improved lung function
• Improved ventilation
• No adverse events

HFCC was shown to be more effective than CPT for every outcome measure




http://www.respirtech.com/pdfs/Kluft.pdf


This large randomized controlled crossover trial compared high frequency chest
compression (HFCC) with professionally administered chest physiotherapy (CPT) in 29
cystic fibrosis (CF) patients hospitalized with acute pulmonary exacerbations. Sputum
weight (wet and dry) was a proxy for efficacy. Results showed nearly three times greater
sputum clearance in the HFCC group.

Title: 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.

Design: A prospective, randomized controlled, cross-over

Method: Twenty-nine hospitalized CF patients with acute pulmonary exacerbations received
randomized treatment with HFCC and CPT

• Two days with each therapy over a 4-day period
• Three 30 minute therapy sessions/day
• Expectorated secretions collected during each 30 minute therapy session
• Twelve specimens per patient
• Wet and dry weights determined gravimetrically
• Means and standard deviations ( X + SD) based on 348 total sputum samples

Results:
Weight CPT/PD (X + SD) HFCC (X+ SD) P VALUE
Wet weight (g) 2.86 + 4.0 6.76 + 9.7 0.001
Dry weight (g) 0.26 + 0.45 0.74 + 2.4 0.01

• HFCC is effective: Dry sputum weights were nearly threefold greater than those
expectorated with professionally administered CPT
• No adverse effects were observed
• Patient tolerance and acceptance were high


http://www.respirtech.com/pdfs/Warwick.pdf

In a long-term study comparing chest physiotherapy (CPT) to high frequency chest
compression (HFCC) in cystic fibrosis (CF) patients, 94% showed positive improvements for percent predicted forced vital capacity (FVC) and forced expiratory volume in one minute (FEV1) after two years of HFCC therapy. Most showed clinical improvement. The long - term FVC and FEV1 gains shown in this study are unprecedented.

Title: 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.

Design: Retrospective

Method: FEV1 scores recorded during 2 years of CPT were compared with scores
during 2 years of subsequent HFCC in sixteen CF patients with mild to severe
lung disease.

• CPT 1 - 4X daily for a mean of 23.2 months (range: 14-27
months)
• 1 - 4X daily HFCC for a mean of 21.6 months (range:7-26 months)
• 30-minutes daily minimum for 5 minutes at each of 6 frequencies
• Individual patient therapy times ranged from 30-240 minutes daily
• Concomitant coughing and huffing techniques used

Results: Two-sided t-test analysis:
• Slopes more positive for FVC and FEV1 during HFCC therapy compared
with manual CPT
• Significance level for both FVC and FEV1: P < 0.001





http://www.respirtech.com/pdfs/Anbar.pdf

This short-term evaluation of the effect of HFCC on pulmonary function compared with
chest physiotherapy (CPT) or alternative therapies in 54 CF patients showed significant
improvements in FEV1 after an average 3 months of HFCC treatment.

Title: Anbar RD, Powell KN, Iannuzzi DM. Short-term effects of ThAIRapy® Vest on
pulmonary functions of cystic fibrosis patients. Am J Respir and Crit Care Med
1998; 157 (Suppl 3): A130.

Design: Retrospective Chart Review

Method: Pulmonary function data gathered by retrospective chart review was analyzed for
54 CF patients meeting inclusion criteria:

• Age > 5 years (average = 17 years)
• Compliant HFCC therapy for at least 6 months
• Average HFCC use = 19 minutes/day (+13 minutes)

Prior use of CPT or not
○ 61% used chest physiotherapy (CPT)
○ 39% had NOT used CPT

Post - HFCC PFT’s were compared with best PFT scores obtained 0-6 months
pre-HFCC

Results: Best PFT results:

12 – 18 mo pre - HFCC FEV1 (+SD) 78+26 FVC (+SD) 95+24
0 – 6 mo pre - HFCC FEV1 (+SD) 76+26 FVC (+SD) 97+24
0 – 6 mo post - HFCC FEV1 (+SD) 82+29 FVC (+SD) 101+26

• FEV1 values improved an average of 8% overall

• FEV1 values improved an average of 7 % in patients using CPT prior to
HFCC
• FEV1 values improved an average of 11% in patients using non-CPT
therapies prior to HFCC
• No adverse events were reported