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

Primary Purpose

Brain Ischemia, Reduction of Cerebral Air Emboli

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bilateral Open Pleurae
Right Pleura Open
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Ischemia focused on measuring Cerebral air emboli, heart surgery

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aortic valve pathology requiring surgery.

Exclusion Criteria:

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

Sites / Locations

  • Department of Cardiothoracic Department, Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral Open Pleurae

Right pleura open

Arm Description

Bilateral open pleurae and usage of right pulmonary vein drainage

Opening of right pleura and usage of left ventricular apical drainage.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Duration of the De-airing Procedure
Duration of the de-airing procedure counted in minutes.

Full Information

First Posted
April 17, 2014
Last Updated
June 30, 2017
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02119871
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia, Reduction of Cerebral Air Emboli
Keywords
Cerebral air emboli, heart surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Open Pleurae
Arm Type
Experimental
Arm Description
Bilateral open pleurae and usage of right pulmonary vein drainage
Arm Title
Right pleura open
Arm Type
Active Comparator
Arm Description
Opening of right pleura and usage of left ventricular apical drainage.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Open Pleurae
Intervention Description
Both pleurae are opened Right pulmonary vein drainage
Intervention Type
Procedure
Intervention Name(s)
Right Pleura Open
Intervention Description
Right pleura open Left ventricular apical drainage
Primary Outcome Measure Information:
Title
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Description
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 Frame
Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes
Title
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Description
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 Frame
Time from cardiac ejection to finished de-airing, an average on 5-10 minutes
Title
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Description
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 Frame
Period of ten minutes after finished de-airing
Title
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Description
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.
Time Frame
0-3 minutes after finished de-airing
Title
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Description
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.
Time Frame
3-6 minutes after finished de-airing
Title
Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Description
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.
Time Frame
7-10 minutes after finished de-airing
Secondary Outcome Measure Information:
Title
Duration of the De-airing Procedure
Description
Duration of the de-airing procedure counted in minutes.
Time Frame
Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aortic valve pathology requiring surgery. Exclusion Criteria: Prior thoracic surgery, Severe chronic obstructive pulmonary disease and/or Emphysema.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bansi Koul, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiothoracic Department, Skane University Hospital
City
Lund
State/Province
Lund, Skåne
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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