跳至主要内容
临床试验/NCT03961425
NCT03961425已完成不适用

Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.

Cardiochirurgia E.H.2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年6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
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

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

发起方
Cardiochirurgia E.H.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Weltert

Professor of Biostatistics, Heart Surgeon

Cardiochirurgia E.H.

研究点 (2)

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