High Frequency Chest Wall Oscillation and Cystic Fibrosis

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

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Usual airway clearance; Device: High Frequency Chest Wall Oscillation (HFCWO)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of cystic fibrosis
• Hospitalised patients admitted with a pulmonary infection
• Forced expiratory volume in one second (FEV1)of 15% predicted or over
• 16 years of age or over

Exclusion Criteria:

• Current severe haemoptysis
• Rib fractures or history of spontaneous rib fractures
• pregnancy
• Lung abscess
• End stage disease
• Requiring more than two assisted treatment sessions per day
• Requiring treatment with positive pressure
• Inability to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Airway Clearance Technique; 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; Other Names: Airway clearance techniques (ACT's)
Experimental: High Frequency Chest Wall Oscillation (HFCWO); 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; Other Names: 'The Vest', Hill Rom Model 205

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean percentage change in forced expiratory volume in one second (FEV1)	7days

Secondary Outcome Measures

Outcome Measure	Time Frame
Wet weight of sputum expectorated	24 hours
Length of time to next course of intravenous antibiotics	Within 6 monthsof completing study
Rate of change of C-reactive protein	7 days

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust; Hill-Rom
• Investigators: Principal Investigator: Margaret Hodson, Imperial College London

Publications and helpful links

General Publications

• Burnham P, Stanford G, Stewart R. Autogenic drainage for airway clearance in cystic fibrosis. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD009595. doi: 10.1002/14651858.CD009595.pub3.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Cystic fibrosis; Airway clearance; High frequency chest wall oscillation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 09/H0708/10