Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function
Substudy of Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength.
Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU.
Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kolding、デンマーク、6000
- Lillebaelt Hospital, Kolding
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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:
- Endotracheally intubated
- Expected time on ventilator > 24 hours
- Age ≥ 18 years
- Informed consent
Exclusion Criteria:
- Severe head trauma where therapeutic coma is indicated
- Therapeutic hypothermia where therapeutic coma is indicated
- Status epilepticus where therapeutic coma is indicated
- Patient has participated in the study before
- Patient is transferred from another ICU with length of stay > 48 hours
- Patient is comatose at admission
- PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Non-sedation
The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive. Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol. |
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アクティブコンパレータ：Sedation with daily wake-up
The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:
After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4. |
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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Physical function
時間枠：3 months after ICU-discharge
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Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index. Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025. |
3 months after ICU-discharge
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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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6 minute walk
時間枠：3 months after ICU-discharge
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Walking distance in the 6 minute walk test at 3 months follow-up
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3 months after ICU-discharge
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Handgrip
時間枠：3 months after ICU-discharge
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Handgrip-strength at 3 month follow-up
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3 months after ICU-discharge
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Thigh muscle size
時間枠：3 months after ICU-discharge
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Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up
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3 months after ICU-discharge
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Biomechanical data
時間枠：3 months after ICU-discharge
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Muscle strength, measured using biomechanical measurements - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at 3 months follow-up
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3 months after ICU-discharge
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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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Biomechanical data
時間枠：Within 24 hours of ICU-discharge
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Muscle strength - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at ICU-discharge.
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Within 24 hours of ICU-discharge
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Handgrip
時間枠：Within 24 hours of ICU-discharge
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Handgrip-strength at ekstubation and at ICU-discharge.
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Within 24 hours of ICU-discharge
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Thigh muscle size
時間枠：Within 24 hours of ICU-discharge
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Muscle size, measured as cross section area of the rectus femoris muscle at ekstubation and at ICU-discharge
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Within 24 hours of ICU-discharge
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Helene K Nedergaard, MD、Lillebaelt Hospital, Kolding
出版物と役立つリンク
一般刊行物
- Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
- Nedergaard HK, Jensen HI, Olsen HT, Strom T, Lauridsen JT, Sjogaard G, Toft P. Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial. J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.
- Nedergaard HK, Jensen HI, Lauridsen JT, Sjogaard G, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
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
キーワード
その他の研究ID番号
- S-20130025a
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