Cerebral Autoregulation and Delirium Study (AUTO-POD)
Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study
調査の概要
詳細な説明
The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary.
If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population.
Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial.
This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups:
Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring.
Control Group: Standard intraoperative blood pressure management according to current institutional practice.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Deep Grewal
- 電話番号：4221 416-340-4800
- メール：deep.grewal@uhn.ca
研究連絡先のバックアップ
- 名前：George Djaiani, MD FRCAFRCPS
- 電話番号：6205 416-340-4800
- メール：george.djaiani@uhn.ca
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
• Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.
Exclusion Criteria:
- Patients with symptomatic cerebrovascular disease.
- History of delirium.
- Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).
- Schizophrenia.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention Group:
Participants randomized to the intervention group will receive individualized intraoperative blood pressure management guided by real-time cerebral autoregulation monitoring to protect against both hypo- and hyper-cerebral perfusion. Cerebral autoregulation will be assessed using the cerebral blood volume reactivity index (VRx), defined as the Pearson correlation coefficient between blood volume index (BVI) and mean arterial pressure (MAP). The lower and upper limits of autoregulation will be identified as the MAP values at which VRx exceeds 0.3. If VRx remains outside the autoregulatory range for more than 60 seconds, the anesthesiologist may intervene to restore MAP within the individualized autoregulatory zone. The type and sequence of interventions will be at the discretion of the attending anesthesiologist. |
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
|
|
アクティブコンパレータ：Control Group:
In the control group, the cerebral oximetry monitor will be electronically blinded, although data will be continuously recorded for subsequent analysis.
Intraoperative blood pressure management will follow current institutional standard practice at the discretion of the attending anesthesiologist.
|
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
|
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 |
|---|---|---|
|
Recruitment rate
時間枠：2 year
|
1. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
|
2 year
|
|
Non-adherence with the protocol
時間枠：2 year
|
Non-adherence with the protocol (percentage of patients with VRx > 0.3 where no intervention was performed; <10%)
|
2 year
|
|
Completeness and quality of POD assessment
時間枠：2 year
|
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
|
2 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall incidence of impaired cerebral autoregulation
時間枠：2 year
|
Overall incidence of impaired cerebral autoregulation in the intervention and control groups.
|
2 year
|
|
Percentage of patients in whom attempted restoration
時間枠：2 year
|
Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
|
2 year
|
|
The number of interventions required
時間枠：2 year
|
The number of interventions required to restore VRx to autoregulation range
|
2 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tertiary Outcomes: . Frequency of POD
時間枠：2 year
|
Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial).
|
2 year
|
|
Tertiary Outcomes: A composite outcome of major end organ dysfunction
時間枠：2 year
|
A composite outcome of major end organ dysfunction defined as major organ morbidity and mortality (MOMM) and all cause 30-day mortality.
|
2 year
|
|
Tertiary Outcomes: Postoperative quality of recovery
時間枠：2 year
|
Postoperative quality of recovery score QoR-15 survey will be performed at baseline, and postoperative days 1 to 3 (or discharge if earlier).
|
2 year
|
協力者と研究者
捜査官
- 主任研究者：George Djaiani、Toronto General Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
- 25-5746
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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