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The Addition of Non-Invasive Ventilation To Airway Clearance Techniques In Adults With Cystic Fibrosis

NCT01885650 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-02

No results posted yet for this study

Summary

Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance.

There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.

At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study.

Research Question:

Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?

Hypothesis

The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.

Conditions

Interventions

OTHER

Airway Clearance Techniques

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Gemma Stanford, BSc (Hons) Physiotherapy · The Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-05-11
Completion
2017-05-11

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01885650 on ClinicalTrials.gov