Tidal Volume Challenge and Lung Recruitment Maneuver(TIDALREC): 유체 반응에 대한 맥박 압박 변동 또는 뇌졸중 용적 변동의 신뢰성. (TIDALEC)
수술 중 혈역학 최적화: 맥박 압력의 변화와 수축기 박출량의 변화를 모니터링하여 일회 호흡량 도전과 폐 동원 기동의 유체 반응성에 대한 예측 값.
In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).
The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lille, 프랑스, 59037
- Hop Claude Huriez Chu Lille
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
- Block duration > 2 hours.
Exclusion Criteria:
- open thoracique surgery
- history of supra ventricular arrhythmias
- beta-blocking patient
- BMI>30 kg.m-2 or <15 kg.min-2
- right ventricular dysfunction
- severe valvulopathies
- intracardiac shunt
- renal failure dialysis
- patient's refusal
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group 1
Starting LRM (Lung Recruitment Maneuver) |
The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times). |
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실험적: Group 2
Starting VtC (Tidal Volume Challenge) |
The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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일회 호흡량 도전(VtC) 동안 맥박 압력(VPP) 변화의 ROC 곡선 아래 면적(AUC).
기간: 전체 수술 기간(평균 3~5시간 예상). 수술 중 여러 번 발생할 수 있는 30분의 시퀀스 동안 측정
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전체 수술 기간(평균 3~5시간 예상). 수술 중 여러 번 발생할 수 있는 30분의 시퀀스 동안 측정
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.
기간: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs of the two techniques calculated above.
기간: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).
기간: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
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The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.
기간: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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Number of complications in pneumothorax
기간: 1 day (at recovery room after surgery) and at day 2
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Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2. |
1 day (at recovery room after surgery) and at day 2
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gilles Lebuffe, MD,PhD, University Hospital, Lille
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- 2019_71
- 2020-A01460-39 (기타 식별자: ID-RCB number,ANSM)
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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