- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119871
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
Status
Completed
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BKML-004
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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