High Frequency Chest Wall Oscillation and Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057524
• Other study ID #: 09/H0708/10
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2010
• Last updated: November 10, 2016
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

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

Locations

Country	Name	City	State
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Hill-Rom, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage change in forced expiratory volume in one second (FEV1)		7days	Yes
Secondary	Wet weight of sputum expectorated		24 hours	Yes
Secondary	Length of time to next course of intravenous antibiotics		Within 6 monthsof completing study	Yes
Secondary	Rate of change of C-reactive protein		7 days	Yes