圧力補助自発呼吸試験後の1時間陽圧換気:ランダム化比較試験
圧サポート自発呼吸トライアル後の1時間陽圧換気:無作為化臨床試験
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on pressure support. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:1) One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.2) Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory.Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Aline B Pereira
- 電話番号:+55 (47) 99181-8400
- メール:linibp@hotmail.com
参加基準
適格基準
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 aged > 18 years.
- Admitted to the intensive care unit (surgical or medical).
- With endotracheal intubation.
- Mechanical ventilation for more than 72 hours.
- Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.
Exclusion Criteria:
- Patients unable to obey commands.
- With non-planned extubation.
- Neuromuscular disease and cervical spinal cord injury.
- Tracheostomy.
- Contraindication for cardiopulmonary resuscitation or reintubation.
- Terminal extubation.
- Lack of informed consent.
- Previously included in the trial.
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:防止
- 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)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:1時間の陽圧換気
|
As soon as the success of the spontaneous breathing trial is confirmed, the patient will be submitted to one-hour positive pressure ventilation using the previous ventilatory parameters and, afterwards, extubated. |
|
アクティブコンパレータ:即時抜管
|
The patient will be extubated immediately (up to 10 minutes) after the success of the spontaneous breathing trial. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Extubation Failure Within 7 Days
時間枠:7 days (from randomization through Day 7 after randomization)
|
Extubation failure is defined as a composite endpoint of reintubation or death within 7 days after randomization |
7 days (from randomization through Day 7 after randomization)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ventilator-Free Days Through Day 28
時間枠:28 days (from randomization through Day 28 after randomization)
|
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation from randomization through Day 28 after randomization. If a patient dies before day 28, the ventilator-free days will be counted as zero. If a patient is reintubated and returns to mechanical ventilation and later is extubated again and remains in unassisted breathing until day 28, the ventilator-free days will be counted from the end of the last period of assisted breathing until day 28. An invasive mechanical ventilation period of less than 24 hours for surgical purposes will count as 1 ventilator-free day. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from mechanical ventilation for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed up until day 28 to assess this outcome. |
28 days (from randomization through Day 28 after randomization)
|
|
Hospital-Free Days Through Day 28
時間枠:28 days (from randomization through Day 28 after randomization)
|
Hospital-free days are defined as the number of days alive and out of the hospital from randomization through Day 28 after randomization. If a patient dies before day 28, the hospital-free days will be counted as zero. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from hospital for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed through day 28 to ascertain this outcome. |
28 days (from randomization through Day 28 after randomization)
|
|
Number of Participants Who Died Within 28 Days
時間枠:28 days (from randomization through Day 28 after randomization)
|
All-cause mortality from randomization through day 28 |
28 days (from randomization through Day 28 after randomization)
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ventilatory Support-Free Days Through Day 28
時間枠:28 days (from randomization through Day 28 after randomization)
|
Ventilatory support-free days are defined as the number of days alive and free from any ventilatory support (invasive or noninvasive) from randomization through day 28. Any use of invasive mechanical ventilation for any duration during a calendar day will count as 1 day with ventilatory support (i.e., not free). Use of noninvasive ventilatory support (noninvasive ventilation or high-flow nasal cannula) for ≥6 hours in any calendar day will count as 1 day with ventilatory support. Participants who die before day 28 will be assigned 0 ventilatory support-free days. If reintubation occurs and the participant later achieves unassisted spontaneous breathing again, ventilatory support-free days will be counted from the end of the last assisted-breathing period through day 28, provided the participant remains alive and free from ventilatory support. |
28 days (from randomization through Day 28 after randomization)
|
|
Number of Participants With Extubation Failure Within 2 Days
時間枠:2 days (from randomization through Day 2 after randomization)
|
Extubation failure is defined as a composite endpoint of reintubation or death within 2 days after randomization |
2 days (from randomization through Day 2 after randomization)
|
|
Number of Participants With Death or Reintubation Within 28 Days
時間枠:28 days (from randomization through Day 28 after randomization)
|
Composite endpoint of reintubation or death within 28 days after randomization |
28 days (from randomization through Day 28 after randomization)
|
|
Intensive Care Unit-Free Days Through Day 28
時間枠:28 days (from randomization through Day 28 after randomization)
|
ICU-free days are defined as the number of days alive and out of the intensive care unit from randomization through day 28. If a patient dies before day 28, the ICU-free days will be counted as zero. Patients discharged from the hospital in unassisted breathing before 28 days will be considered as alive and free from ICU for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed up until day 28 to assess this outcome. |
28 days (from randomization through Day 28 after randomization)
|
|
Number of Participants Who Died in the Hospital
時間枠:From randomization to hospital discharge, up to 90 days
|
All-cause mortality occurring from randomization until hospital discharge (death before hospital discharge) |
From randomization to hospital discharge, up to 90 days
|
|
Number of Participants Who Died in the Intensive Care Unit
時間枠:From randomization to ICU discharge, up to 90 days
|
All-cause mortality occurring from randomization until ICU discharge (death before ICU discharge) |
From randomization to ICU discharge, up to 90 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
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