CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
研究概览
简要总结
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
详细描述
Study design:
Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be blinded to the de-airing technique used (the recorded videos will be analyzed at the end of the study). The TCD monitoring will be done by on-line automatic recording of the micro embolic signals (MES) from the right and or left middle cerebral arteries and performed by single surgeon. The CO2 insufflation of the operating field will be performed according to manufacturer's guide lines. During entire study course one type of extracorporeal perfusion system will be used.The study will be registered in the international database. A prior approval will be sought from the hospital ethical committee for the study.
Patient selection:
Patients planned for aortic valve/root replacement or repair will be selected for the study
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for aortic valve/root replacement or repair will be selected for the study
排除标准
- •Patients with known
- •chronic obstructive pulmonary disease,
- •emphysema,
- •previous thoracic or cardiac surgery,
- •history of CVA or stroke and
- •evidence of intraoperative pleural adhesions will be excluded from the study.
- •Patients requiring internal mammary artery coronary bypass will also be excluded.
研究组 & 干预措施
Lund de-airing
Lund de-airing technique
干预措施: Lund de-airing technique (Procedure)
Carbon-dioxide insufflation
carbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner
干预措施: carbon-dioxide insufflation (Drug)
结局指标
主要结局
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
时间窗: During 10 minutes after cardiopulmonary bypass
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
时间窗: 6-10 minutes after end of cardiopulmonary bypass
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
次要结局
- Total Time Required for De-airing(After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes)
- De-airing Time Before Cardiac Ejection(Measured during intraoperative course)
- De-airing Time After Cardiac Ejection(During de-airing procedure)
- Oxygenator Gas Flow at 45 Minutes of CPB(Intraoperative)
- pH at 45 Min of CPB(Intraoperative)
研究者
Bansi Lal Koul
Chief Surgeon and Associate Professor
Lund University