NCT02678559已完成不适用
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Variation of stroke volume
研究概览
简要总结
The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.
详细描述
Population studied: anesthetized patients for cardiac surgery of coronary bypass.
Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)
- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected
排除标准
- •Emergency case
- •Pericardial effusion
- •Aortic or mitral valvulopathy
- •Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
- •Bad echogenicity
- •Patient refusal to participate to the study
- •No health insurance
结局指标
主要结局
Variation of stroke volume
时间窗: at the beginning of cardiac surgery
Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery
次要结局
- Pulse pressure variation (%) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Perfusion index (pulsoxymeter)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Right ventricle diameter/left ventricle diameter ratio(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Cardiac index (l/min/m2)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- E/A ratio(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Sus-hepatic vein Doppler profile(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Heart rate (pulse/min)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Invasive arterial pressure (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Stroke volume variation (%) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Velocity time integral (cm)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Cardiac index (l/min/m2) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Expired CO2 (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Arterial pressure (mmHg) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Central venous pressure (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Stroke volume (ml) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Stroke volume variation (%) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Stroke volume (ml) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Pulse pressure variation (%)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Cardiac index (l/min/m2) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Near infrared spectroscopy : Cerebral SrO2(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Arterial pressure (mmHg) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
- Pulse pressure variation (%) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
研究者
研究点 (2)
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