- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02055807
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.
연구 개요
상태
정황
상세 설명
Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results.
On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring. Ventilator settings will be adjusted according to randomization.
A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia.
Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H2L 4M1
- Centre Hospitalier de l'Universite de Montreal (CHUM)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients aged 18 years and older
- Scheduled for surgery by laparotomy (expected to last at least 2 hours)
- American Society of Anesthesiologists classification: physical status 1-3
Exclusion Criteria:
- Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
- Contraindication to the placement of an arterial line
- Very severe chronic obstructive pulmonary disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: PEEP and recruitment maneuvers
A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery.
Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation.
Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.
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활성 비교기: ZEEP (Zero end-expiratory pressure)
No PEEP nor recruitment maneuvers will be used during surgery.
Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Lung aeration
기간: Post-induction to pre-emergence of anesthesia - Day 0
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Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).
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Post-induction to pre-emergence of anesthesia - Day 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Re-aeration following recruitment maneuvers
기간: Prior and after the first recruitment maneuver during general anesthesia - Day 0
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Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).
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Prior and after the first recruitment maneuver during general anesthesia - Day 0
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Atelectasis secondary to induction
기간: Lung aeration score prior and after intubation - Day 0
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Estimate development of atelectasis secondary to intubation.
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Lung aeration score prior and after intubation - Day 0
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Atelectasis secondary to extubation
기간: Lung aeration score prior and after extubation - Day 0
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Estimate development of atelectasis secondary to extubation.
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Lung aeration score prior and after extubation - Day 0
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
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