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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Manchester
-
Wythenshawe、Manchester、英国、M23 9LT
- 招聘中
- Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
-
首席研究员：
- Susan C Johnson, MSc MCSP
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Non invasive ventilation (NIV)
Non invasive ventilation used for the first 7 days of study
|
其他名称：
|
|
有源比较器：Standard Care
High Flow Controlled Oxygen Therapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in day time carbon dioxide (CO2)
大体时间：Day 7
|
Day 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Early morning oxygen (O2) and CO2 levels
大体时间：days 1,3,5,7,10 and 14
|
days 1,3,5,7,10 and 14
|
|
|
Lung function (FEV1 and FVC)
大体时间：Day 7, 14
|
Day 7, 14
|
|
|
Respiratory Rate
大体时间：days 1,3,5,7,10 and 14
|
days 1,3,5,7,10 and 14
|
|
|
Heart Rate
大体时间：Days 1,3,5,7,10 and 14
|
Days 1,3,5,7,10 and 14
|
|
|
Symptom score (CFRSD)
大体时间：days 1,3,5,7,10 and 14
|
Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)
|
days 1,3,5,7,10 and 14
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Semi structured interview
大体时间：Day 14
|
Psychologist delivered semi structured interview discussing participant experience of non invasive ventilation (NIV)
|
Day 14
|
合作者和调查者
调查人员
- 首席研究员：Susan C Johnson, MSC MCSP、Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
标准护理的临床试验
-
Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
-
Compedica IncProfessional Education and Research Institute招聘中
-
Integra LifeSciences CorporationIntegrium终止
-
Cishan Hospital, Ministry of Health and Welfare完全的
-
DeRoyal Industries, Inc.Lincoln Memorial University完全的
-
National Institute of Allergy and Infectious Diseases...Institut National de la Santé Et de la Recherche Médicale, France; The Ministry of Health and... 和其他合作者完全的
-
Spaulding Rehabilitation HospitalGoldenGait LTD招聘中