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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Deep Grewal
- 전화번호: 4221 416-340-4800
- 이메일: deep.grewal@uhn.ca
연구 연락처 백업
- 이름: George Djaiani, MD FRCAFRCPS
- 전화번호: 6205 416-340-4800
- 이메일: george.djaiani@uhn.ca
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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활성 비교기: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate
기간: 2 year
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1. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
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2 year
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Non-adherence with the protocol
기간: 2 year
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Non-adherence with the protocol (percentage of patients with VRx > 0.3 where no intervention was performed; <10%)
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2 year
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Completeness and quality of POD assessment
기간: 2 year
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Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
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2 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall incidence of impaired cerebral autoregulation
기간: 2 year
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Overall incidence of impaired cerebral autoregulation in the intervention and control groups.
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2 year
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Percentage of patients in whom attempted restoration
기간: 2 year
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Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
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2 year
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The number of interventions required
기간: 2 year
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The number of interventions required to restore VRx to autoregulation range
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2 year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tertiary Outcomes: . Frequency of POD
기간: 2 year
|
Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial).
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2 year
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Tertiary Outcomes: A composite outcome of major end organ dysfunction
기간: 2 year
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A composite outcome of major end organ dysfunction defined as major organ morbidity and mortality (MOMM) and all cause 30-day mortality.
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2 year
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Tertiary Outcomes: Postoperative quality of recovery
기간: 2 year
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Postoperative quality of recovery score QoR-15 survey will be performed at baseline, and postoperative days 1 to 3 (or discharge if earlier).
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2 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: George Djaiani, Toronto General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-5746
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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