Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound (AKE-MECC)
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
연구 개요
상태
정황
상세 설명
Background
The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.
Methods
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Bern, 스위스, 3010
- University Hospital Bern
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Isolated Severe Aortic Valve Stenosis
- No other cardiac disease
- No other coronary heart disease
- Written informed consent
Exclusion Criteria
- Double valve surgery
- Concomitant coronary artery bypass surgery
- Vascular surgery
- Age < 18 yrs.
- Age > 80 yrs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Conventional Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using CECC.
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실험적: Minimized Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using MECC.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Total and interval-related cerebral microembolic load as measured by transcranial Doppler
기간: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
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Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
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2차 결과 측정
결과 측정 |
기간 |
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Cerebral complications, e.g. delirium and stroke as detected clinically
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Redo surgery
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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ICU length of stay
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Extubation time
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Thromboembolic complications
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital infections
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital Mortality
기간: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thierry Carrel, MD, PhD, Department of Cardiovascular Surgery
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 034/11
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Conventional Extracorporeal Circulation (CECC)에 대한 임상 시험
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