Clinical trial NCT02119871: Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing
Official title: Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Ischemia
Reduction of Cerebral Air Emboli
Keywords: Cerebral air emboli, heart surgery
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Aortic valve pathology requiring surgery.

Exclusion Criteria:

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

Primary outcomes:
measure: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
timeFrame: Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes
measure: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
timeFrame: Time from cardiac ejection to finished de-airing, an average on 5-10 minutes
measure: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
timeFrame: Period of ten minutes after finished de-airing
measure: Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
timeFrame: 0-3 minutes after finished de-airing
measure: Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
timeFrame: 3-6 minutes after finished de-airing
measure: Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
timeFrame: 7-10 minutes after finished de-airing
Secondary outcomes:
measure: Duration of the De-airing Procedure
timeFrame: Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Cardiothoracic Department, Skane University Hospital
state: Lund, Skåne
Study officials:
affiliation: Lund University
name: Bansi Koul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: