Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing

Not Applicable

Completed

• Conditions: Reduction of Cerebral Air Emboli; Brain Ischemia
• Interventions: Procedure: Bilateral Open Pleurae; Procedure: Right Pleura Open

• Registration Number: NCT02119871
• Lead Sponsor: Lund University

Brief Summary

To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral pulmonary collapse for cardiac de-airing in open left-sided heart surgery.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2017-03-28
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-30
• Last Update Submitted: 2017-06-30
• Results First Posted: 2018-01-29
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Aortic valve pathology requiring surgery.

Exclusion Criteria

• Prior thoracic surgery,
• Severe chronic obstructive pulmonary disease and/or
• Emphysema.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral Open Pleurae	Bilateral Open Pleurae	Bilateral open pleurae and usage of right pulmonary vein drainage
Right pleura open	Right Pleura Open	Opening of right pleura and usage of left ventricular apical drainage.

Primary Outcome Measures

Name	Time	Method
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Duration of the de-airing procedure counted in minutes.

Trial Locations

Locations (1)

Department of Cardiothoracic Department, Skane University Hospital; 🇸🇪 Lund, Lund, Skåne, Sweden