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

• Sponsor: Lund University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02119871
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Ischemia; Reduction of Cerebral Air Emboli	Procedure: Bilateral Open Pleurae; Procedure: Right Pleura Open	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery [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.

2. Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery [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.

3. Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery [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.

4. Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. [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.

5. Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. [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.

6. Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. [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.

Secondary Outcome Measures

1. Duration of the De-airing Procedure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aortic valve pathology requiring surgery.

Exclusion Criteria:

• Prior thoracic surgery,

• Severe chronic obstructive pulmonary disease and/or

• Emphysema.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiothoracic Department, Skane University Hospital	Lund	Lund, Skåne	Sweden	221 85

Sponsors and Collaborators

• Lund University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bansi Lal Koul, Lund University, Lund University
• ClinicalTrials.gov Identifier: NCT02119871
• Other Study ID Numbers: BKML-004
• First Posted: Apr 22, 2014
• Last Update Posted: Jan 29, 2018
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Bansi Lal Koul, Lund University, Lund University: Cerebral air emboli, heart surgery
• Additional relevant MeSH terms: Pulmonary Atelectasis; Brain Ischemia; Embolism; Embolism, Air; Ischemia

Study Results

Participant Flow

Recruitment Details	Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open	Total
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	69	71	70
Sex: Female, Male (Count of Participants)
Female	3 30%	4 40%	7 35%
Male	7 70%	6 60%	13 65%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Sweden	10 100%	10 100%	20 100%
Body surface area (m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [m^2]	1.97	1.93	1.97

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent (LVAV) in order to evaluate:1. the impact on de-airing of unilateral open pleura compared to bilateral open pleurae, and 2. the impact on de-airing of a right superior pulmonary vein vent compared to LVAV.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Median (Inter-Quartile Range) [gaseous cerebral microemboli]	46	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bilateral Open Pleurae, Right Pleura Open
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	14
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Median (Inter-Quartile Range) [gaseous cerebral microemboli]	31	41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bilateral Open Pleurae, Right Pleura Open
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.656
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	10
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Median (Inter-Quartile Range) [gaseous cerebral microemboli]	30	34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bilateral Open Pleurae, Right Pleura Open
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Count of Participants [Participants]	8 80%	9 90%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Count of Participants [Participants]	9 90%	10 100%

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Count of Participants [Participants]	9 90%	10 100%

7. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.

Arm/Group Title	Bilateral Open Pleurae	Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Measure Participants	10	10
Median (Inter-Quartile Range) [minutes]	8	10

Adverse Events

Time Frame	Adverse event data were collected during the inpatient care period after surgery, approximately 1 week.
Arm/Group Title	Bilateral Open Pleurae		Right Pleura Open
Arm/Group Description	Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage		Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
All Cause Mortality
	Bilateral Open Pleurae		Right Pleura Open
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Bilateral Open Pleurae		Right Pleura Open
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Bilateral Open Pleurae		Right Pleura Open
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)
Nervous system disorders
Neurological deficit	1/10 (10%)	1	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.