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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
Manchester
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Wythenshawe、Manchester、イギリス、M23 9LT
- 募集
- Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
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主任研究者：
- Susan C Johnson, MSc MCSP
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Non invasive ventilation (NIV)
Non invasive ventilation used for the first 7 days of study
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他の名前：
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アクティブコンパレータ：Standard Care
High Flow Controlled Oxygen Therapy
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in day time carbon dioxide (CO2)
時間枠：Day 7
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Day 7
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Early morning oxygen (O2) and CO2 levels
時間枠：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)
時間枠：Day 7, 14
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Day 7, 14
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Respiratory Rate
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Semi structured interview
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Susan C Johnson, MSC MCSP、Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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