Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
研究概览
简要总结
To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral pulmonary collapse for cardiac de-airing in open left-sided heart surgery.
详细描述
Effective removal of air from the heart before termination of cardiopulmonary bypass (CPB) is vital in open left heart surgery. Bilateral collapse of the lungs during cardiopulmonary bypass decreases the duration of the de-airing procedure, decreases residual air emboli monitored on Trans-esophageal Echocardiography (TEE) and decreases gaseous cerebral microemboli (MES) monitored by Trans-cranial Echo-Doppler (TCD) when compared to expanded lungs during (CPB). Induced pulmonary collapse by opening of the pleura and disconnection of the patient from the ventilator during CPB decreases the amount of air that can enter the pulmonary veins. Not all surgeons wish to induce lung collapse from fraught that it might lead to pulmonary ischemia or infection. It is unknown whether collapse of only the right lung is as effective as collapse of both lungs.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic valve pathology requiring surgery.
排除标准
- •Prior thoracic surgery,
- •Severe chronic obstructive pulmonary disease and/or
- •Emphysema.
研究组 & 干预措施
Bilateral Open Pleurae
Bilateral open pleurae and usage of right pulmonary vein drainage
干预措施: Bilateral Open Pleurae (Procedure)
Right pleura open
Opening of right pleura and usage of left ventricular apical drainage.
干预措施: Right Pleura Open (Procedure)
结局指标
主要结局
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
时间窗: Period of ten minutes after finished de-airing
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
时间窗: 7-10 minutes after finished de-airing
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.
次要结局
- Duration of the De-airing Procedure(Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.)
研究者
Bansi Lal Koul
Lund University
Lund University