Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Time to Complete Deairing
研究概览
简要总结
Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up
详细描述
The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine, and flooding the surgical field with CO2, which is heavier than Azote and Oxygen but over ten times more soluble seems a promising technique to minimize the presence of air microemboli. However very few studies have been conducted to ascertain what is the most efficient way to administer this treatment, or even of this treatment really impacts deairing time and clinical neurological events.
This study aims at comparing the use of CO2 (administered in two different ways: a simple cannula, which might be prone to emulsioning air and CO2 not reaching a complete CO2 saturation and a specific commercial diffuser which states promises complete filed saturation) to the no-CO2 standard approach.
The primary end point will be Time to Complete deairing as measured by intraoperative transesophageal echo while the secondary end point will be the incidence of clinical neurological events the day after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical Outcomes are assessed by ICU physicians and the intraoperative strategy is not disclosed
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
排除标准
- •any other kind of operation
结局指标
主要结局
Time to Complete Deairing
时间窗: Intraoperative
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
次要结局
- Neurological Events at Wake Up(The day after operation)
研究者
Luca Weltert
Professor of Biostatistics, Heart Surgeon
Cardiochirurgia E.H.
