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

June 30, 2017 updated by: Bansi Lal Koul, Lund University

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lund, Skåne
      • Lund, Lund, Skåne, Sweden, 221 85
        • Department of Cardiothoracic Department, Skane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aortic valve pathology requiring surgery.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral Open Pleurae
Bilateral open pleurae and usage of right pulmonary vein drainage
Both pleurae are opened Right pulmonary vein drainage
Active Comparator: Right pleura open
Opening of right pleura and usage of left ventricular apical drainage.
Right pleura open Left ventricular apical drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time Frame: Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes
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
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time Frame: Time from cardiac ejection to finished de-airing, an average on 5-10 minutes
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
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time Frame: 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.
Period of ten minutes after finished de-airing
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time Frame: 0-3 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.
0-3 minutes after finished de-airing
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time Frame: 3-6 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.
3-6 minutes after finished de-airing
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time Frame: 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.
7-10 minutes after finished de-airing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the De-airing Procedure
Time Frame: 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.
Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Bansi Koul, MD, PhD, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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