跳至主要内容
临床试验/NCT04202575
NCT04202575Unknown不适用

Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery Using a Separate Reservoir for Suction of Blood From the Open Surgical Wound

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Difference in PaCO2 (kPa)

研究概览

简要总结

The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.

详细描述

Background: CO2-gas insufflation is used for continuous de-airing during open heart surgery. The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant.

Methods: A separate small reservoir are used during CPB in addition to a standard large venous reservoir. The small reservoir receive drained wound blood and CO2-gas continuously via a suction drain (1 L/min) and handheld suction devices from the open surgical wound. CO2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 L/min. During cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of PaCO2 is observed, after adjustment of sweep gas flow as necessary. Mean values for each setup (2-4 times) for each patient will be analyzed with Wilcoxon rank-sum test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
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

入选标准

  • adult patients undergoing open heart replacement of the aortic valve
  • Use of perioperative cardiopulmonary bypass

排除标准

  • Denied participation in the study

结局指标

主要结局

Difference in PaCO2 (kPa)

时间窗: At 5 minutes steady state

次要结局

  • Oxygenator sweep gas flow rate (L/min)(At 5 minutes steady state)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan van der Linden

Professor

Karolinska University Hospital

研究点 (1)

Loading locations...

相似试验