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

Brain Ischemia Clinical Trial

Official title:

Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119871
• Other study ID #: BKML-004
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: June 30, 2017
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2017
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Aortic valve pathology requiring surgery.

Exclusion Criteria:

• Prior thoracic surgery,

• Severe chronic obstructive pulmonary disease and/or

• Emphysema.

Related Conditions & MeSH terms

• Brain Ischemia
• Embolism
• Embolism, Air
• Ischemia
• Pulmonary Atelectasis
• Reduction of Cerebral Air Emboli

Intervention

Procedure:
• Bilateral Open Pleurae
Both pleurae are opened Right pulmonary vein drainage
• Right Pleura Open
Right pleura open Left ventricular apical drainage

Locations

Country	Name	City	State
Sweden	Department of Cardiothoracic Department, Skane University Hospital	Lund	Lund, Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	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.	Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes
Primary	Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	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.	Time from cardiac ejection to finished de-airing, an average on 5-10 minutes
Primary	Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	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.	Period of ten minutes after finished de-airing
Primary	Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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.	0-3 minutes after finished de-airing
Primary	Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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.	3-6 minutes after finished de-airing
Primary	Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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.	7-10 minutes after finished de-airing
Secondary	Duration of the De-airing Procedure	Duration of the de-airing procedure counted in minutes.	Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.