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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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)
- Early morning and day time carbon dioxide (CO2) level.
- Day time oxygen levels
- Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
- Day time resting Respiratory Rate (RR), Heart Rate (HR)
- 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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Manchester
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Wythenshawe, Manchester, Verenigd Koninkrijk, M23 9LT
- Werving
- Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
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Hoofdonderzoeker:
- Susan C Johnson, MSc MCSP
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Non invasive ventilation (NIV)
Non invasive ventilation used for the first 7 days of study
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Andere namen:
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Actieve vergelijker: Standard Care
High Flow Controlled Oxygen Therapy
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in day time carbon dioxide (CO2)
Tijdsspanne: Day 7
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Day 7
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Early morning oxygen (O2) and CO2 levels
Tijdsspanne: days 1,3,5,7,10 and 14
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days 1,3,5,7,10 and 14
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Lung function (FEV1 and FVC)
Tijdsspanne: Day 7, 14
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Day 7, 14
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Respiratory Rate
Tijdsspanne: days 1,3,5,7,10 and 14
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days 1,3,5,7,10 and 14
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Heart Rate
Tijdsspanne: Days 1,3,5,7,10 and 14
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Days 1,3,5,7,10 and 14
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Symptom score (CFRSD)
Tijdsspanne: days 1,3,5,7,10 and 14
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Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)
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days 1,3,5,7,10 and 14
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Semi structured interview
Tijdsspanne: Day 14
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Psychologist delivered semi structured interview discussing participant experience of non invasive ventilation (NIV)
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Day 14
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Susan C Johnson, MSC MCSP, Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1199
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