Non Invasive Ventilation for Acute Exacerbations in Adult CF

NCT02234401 | Unknown

• 1 other identifier: 1199
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years (UK CF Registry 2011). The commonest cause of death is respiratory failure. Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the size and depth of each breath. It is introduced in CF to manage established respiratory failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation, is used just at night, or for part of the day in addition or for 24 hours as clinical status indicates. It is introduced within a normal ward environment and then continued longterm at home.Once respiratory failure is established longterm noninvasive ventilation is introduced throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate for the individual. This study aims to evaluate a potential development of current practice: the use of non invasive ventilation during hospital admission only to enhance recovery from an acute exacerbation which has caused respiratory failure in those individuals where long term non invasive ventilation is not yet indicated. A mixed methods design will allow description of the experience of noninvasive ventilation during a semistructured interview to add to understanding of the results from an experiment designed to measure the differences between noninvasive ventilation and standard care. Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.

Conditions

Cystic Fibrosis; Respiratory Failure

Keywords

Cystic Fibrosis; Noninvasive ventilation; Non invasive ventilation; Acute respiratory exacerbation; Bi level pressure support

Outcome Measures

Primary Outcomes (1)

• Change in day time carbon dioxide (CO2)

  Day 7

Secondary Outcomes (5)

• Early morning oxygen (O2) and CO2 levels

  days 1,3,5,7,10 and 14

• Lung function (FEV1 and FVC)

  Day 7, 14

• Respiratory Rate

  days 1,3,5,7,10 and 14

• Heart Rate

  Days 1,3,5,7,10 and 14

• Symptom score (CFRSD)

  days 1,3,5,7,10 and 14

Other Outcomes (1)

• Semi structured interview

  Day 14

Study Arms (2)

Non invasive ventilation (NIV)

EXPERIMENTAL

Non invasive ventilation used for the first 7 days of study

Device: Bi level pressure support

Standard Care

ACTIVE COMPARATOR

High Flow Controlled Oxygen Therapy

Other: Standard Care

Interventions

Bi level pressure support DEVICE

Also known as: Noninvasive ventilation, NIV

Non invasive ventilation (NIV)

Standard Care OTHER

Standard Care

Eligibility Criteria

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

You may qualify if:

• Adult Cystic Fibrosis
• Hospital admission to Pearce Ward Manchester Adult Cystic Fibrosis Centre
• Acute respiratory exacerbation conforming with a standard definition of pulmonary exacerbation (Fuchs et al 1994).
• An admission day time CO2 \> 6 kilopascal (kPa) on standard therapy
• Freely given informed consent.-
• substantial amendment approval for an admission early morning CO2 \> 6 kPa

You may not qualify if:

• A day time CO2 \>8.0 kPa
• respiratory acidosis

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester

Wythenshawe, Manchester, M23 9LT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Insufficiency

Interventions

Noninvasive Ventilation; Standard of Care

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; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan C Johnson, MSC MCSP

  Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan C Johnson, MSc MCSP

CONTACT

0161291; susan.johnson@uhsm.nhs.uk

Rowland BrightThomas, MB ChB, MRCP, MD

CONTACT

0161291; Rowland.brighthomas@uhsm.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physiotherapist

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

GB (1)