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

NCT01885650 | Terminated DMC

• 1 other identifier: 13/LO/0565
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Cystic Fibrosis

Keywords

Non invasive ventilation; Chest physiotherapy; Airway clearance

Outcome Measures

Primary Outcomes (1)

• Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight

  The amount of sputum expectorated by the patient both up to 30 minutes after treatment, and the total amount cleared in 24 hours after each treatment

  24 hours

Secondary Outcomes (3)

• Qualitative assessment using 10 centimetre Visual Analogue Scale (VAS) of ease of clearance, work of breathing during clearance and satisfaction of each treatment approach (A or B).

  Within 5 minutes immediately after each treatment

• Lung function tests

  5 minutes before treatment, within 5 minutes immediately after treatment and 30 minutes after treatment

• Oxygen saturations during the treatment session

  During the treatment

Other Outcomes (1)

• Final Evaluation Questionnaire

  At the end of each participants study period. These will be completed up to 30 minutes after the final treatment on the final day of the research study.

Study Arms (2)

Normal airway clearance

EXPERIMENTAL

The patients usual airway clearance technique

Other: Airway Clearance Techniques

Non-Invasive Ventilation

EXPERIMENTAL

The addition of positive pressure via a non-invasive ventilator to the participants usual airway clearance technique

Other: Airway Clearance Techniques

Interventions

Airway Clearance Techniques OTHER

Non-Invasive Ventilation; Normal airway clearance

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of \>70mmol/l or sweat chloride of \>60mmol/l)
• Sixteen years of age or over
• Patients with an established airway clearance regime that they have used for 3 months or more

You may not qualify if:

• Current moderate haemoptysis (greater than streaking in the sputum)
• Current pneumothorax or history of pneumothorax in the 3 months prior to consideration for the study
• Current dependency on positive pressure support with airway clearance via the IPPB (Intermittent Positive Pressure Breathing) machine or NIV
• Previous history of spontaneous rib fractures
• Pregnancy
• Inability to give consent for treatment or measurement
• Current participation in another study
• If the patient requires more than 2 airway clearance sessions a day

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

The Royal Brompton Hospital

London, Greater London, SW3 6NP, United Kingdom

Location

Related Publications (9)

• Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.

  PMID: 7697269 BACKGROUND

• Fauroux B, Boule M, Lofaso F, Zerah F, Clement A, Harf A, Isabey D. Chest physiotherapy in cystic fibrosis: improved tolerance with nasal pressure support ventilation. Pediatrics. 1999 Mar;103(3):E32. doi: 10.1542/peds.103.3.e32.

  PMID: 10049988 BACKGROUND

• Holland AE, Denehy L, Ntoumenopoulos G, Naughton MT, Wilson JW. Non-invasive ventilation assists chest physiotherapy in adults with acute exacerbations of cystic fibrosis. Thorax. 2003 Oct;58(10):880-4. doi: 10.1136/thorax.58.10.880.

  PMID: 14514944 BACKGROUND

• Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol. 1997 Aug;24(2):137-42; discussion 159-61. doi: 10.1002/(sici)1099-0496(199708)24:23.0.co;2-3.

  PMID: 9292910 BACKGROUND

• Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010 Mar;65(3):196-200. doi: 10.1136/thx.2008.111492. Epub 2009 Aug 23.

  PMID: 19703826 BACKGROUND

• Placidi G, Cornacchia M, Polese G, Zanolla L, Assael BM, Braggion C. Chest physiotherapy with positive airway pressure: a pilot study of short-term effects on sputum clearance in patients with cystic fibrosis and severe airway obstruction. Respir Care. 2006 Oct;51(10):1145-53.

  PMID: 17005060 BACKGROUND

• Pryor JA, Tannenbaum E, Scott SF, Burgess J, Cramer D, Gyi K, Hodson ME. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010 May;9(3):187-92. doi: 10.1016/j.jcf.2010.01.004. Epub 2010 Feb 12.

  PMID: 20153269 BACKGROUND

• Zach MS. Lung disease in cystic fibrosis--an updated concept. Pediatr Pulmonol. 1990;8(3):188-202. doi: 10.1002/ppul.1950080311. No abstract available.

  PMID: 2190148 BACKGROUND

• Stanford G, Parrott H, Bilton D, Agent P, Banya W, Simmonds N. Randomised cross-over trial evaluating the short-term effects of non-invasive ventilation as an adjunct to airway clearance techniques in adults with cystic fibrosis. BMJ Open Respir Res. 2019 Apr 14;6(1):e000399. doi: 10.1136/bmjresp-2018-000399. eCollection 2019.

  PMID: 31179002 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Gemma Stanford, BSc (Hons) Physiotherapy

  The Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 25, 2013
• Study Start: July 1, 2013
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

GB (1)