- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04813250
Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography
The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery
Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Neihu Dist
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Taipei City, Neihu Dist, 대만, 11490
- Department of Anesthesiology, Tri-Service General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 20-80 year-old
- Adult patients receiving elective cardiac surgery with hypothermic CPB
Exclusion Criteria:
- Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: Group R
IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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실험적: Group RP
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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실험적: Group RI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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실험적: Group RPI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The correlation between Different ventilation mode and the relevant value of EIT
기간: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The demographic characteristics and relevant value of EIT
기간: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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If the different ventilation mode setting can improve clinical outcome
기간: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Identify the different ventilation mode setting in open heart surgery patient if can improve clinical care benifit.
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The correlation between heart function & oxygenation and different ventilation mode
기간: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Survey the correlation between heart function & oxygenation and different ventilation mode
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
- Ventilatory with EIT post CPB
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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