Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
調査の概要
詳細な説明
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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-
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London、イギリス、SW3 6NP
- Royal Brompton Hospital
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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:
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Exclusion Criteria:
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
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：autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
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Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
他の名前：
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アクティブコンパレータ：Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
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Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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pH at 1+ hour
時間枠：1 hour
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pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
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1 hour
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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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pH at 4+ hours
時間枠：4+ hours of NIV treatment
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pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
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4+ hours of NIV treatment
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Respiratory Rate at 1+ hour
時間枠：1+ hour of NIV treatment
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Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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Respiratory rate at 4+ hours
時間枠：4+ hours of NIV treatment
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Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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overnight mean transcutaneous carbon dioxide
時間枠：24 hours
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mean overnight transcutaneous carbon dioxide during sleep period
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24 hours
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PaCO2 at 1+ hours
時間枠：1+ hours of NIV treatment
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Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
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1+ hours of NIV treatment
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PaCO2 at 4+ hours
時間枠：4+ hours of NIV treatment
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Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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PaO2 at 1+ hour
時間枠：1+ hour of NIV treatment
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Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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PaO2 at 4+ hours
時間枠：4+ hours of NIV treatment
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Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 10/H0808/56
- R&D No. 2010LF008B (その他の識別子：Research & Development Department, RBH)
- CI/2010/0027 (その他の識別子：Medicines & Healthcare Products Regularoty Agency (devices))
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