Non Invasive Ventilation for Acute Exacerbations in Adult CF (NIVinCF)

A Mixed Methods Study Comparing the Clinical Efficacy With the Patient Experience of Non-invasive Ventilation During an Acute Exacerbation Complicated by Respiratory Failure in Adult Cystic Fibrosis

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure; Cystic Fibrosis
• Intervention / Treatment: Other: Standard Care; Device: Bi level pressure support

Detailed Description

Design: The study will use a mixed methodology and it will be in 2 phases. Phase I A group randomised controlled trial

The following measurements will be performed on days 1, 3, 7, 10, 14 and twice weekly until discharge:

The exact timing of measurements will be planned by the participant and the researcher.

All of the outcome measures form part of routine clinical practice except the symptom score; the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD V2.0) (Goss et al., 2009)

1. Early morning and day time carbon dioxide (CO2) level.
2. Day time oxygen levels
3. Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
4. Day time resting Respiratory Rate (RR), Heart Rate (HR)
5. Symptom score CFRSD

Phase II A qualitative exploration of the experience of using NIV for adults with Cystic Fibrosis during an acute exacerbation

Methods: Prior to discharge a semistructured interview designed to explore the experience of using noninvasive ventilation will be undertaken by a clinical psychologist from the Cystic Fibrosis multidisciplinary team. The interviews will be undertaken purely for the research project, recorded and transcribed verbatim by the lead investigator. Thematic analysis will be undertaken to interpret and explore the individual's experience. Credibility checking of interpretation will be undertaken by the clinical psychologists and within academic supervision sessions.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester
    • Wythenshawe, Manchester, United Kingdom, M23 9LT
      • Recruiting
      • Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
      • Principal Investigator: Susan C Johnson, MSc MCSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.-
• 24.3.15 substantial amendment approval for an admission early morning CO2 > 6 kPa

Exclusion Criteria:

• A day time CO2 >8.0 kPa
• respiratory acidosis
• clinical exclusion by CF consultant physician or clinical psychologist

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non invasive ventilation (NIV); Non invasive ventilation used for the first 7 days of study	Device: Bi level pressure support; Other Names: NIV; Noninvasive ventilation
Active Comparator: Standard Care; High Flow Controlled Oxygen Therapy	Other: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in day time carbon dioxide (CO2)	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)	days 1,3,5,7,10 and 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi structured interview	Psychologist delivered semi structured interview discussing participant experience of non invasive ventilation (NIV)	Day 14

Collaborators and Investigators

• Sponsor: Manchester Metropolitan University
• Collaborators: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Susan C Johnson, MSC MCSP, Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Non invasive ventilation; Noninvasive ventilation; Acute respiratory exacerbation; Bi level pressure support
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Respiratory Insufficiency; Cystic Fibrosis
• Other Study ID Numbers: 1199