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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Manchester
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Wythenshawe, Manchester, Reino Unido, M23 9LT
- Recrutamento
- Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
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Investigador principal:
- Susan C Johnson, MSc MCSP
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Non invasive ventilation (NIV)
Non invasive ventilation used for the first 7 days of study
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Outros nomes:
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Comparador Ativo: Standard Care
High Flow Controlled Oxygen Therapy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change in day time carbon dioxide (CO2)
Prazo: Day 7
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Day 7
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Early morning oxygen (O2) and CO2 levels
Prazo: 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)
Prazo: Day 7, 14
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Day 7, 14
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Respiratory Rate
Prazo: 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
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Semi structured interview
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan C Johnson, MSC MCSP, Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1199
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