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To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral pulmonary collapse for cardiac de-airing in open left-sided heart surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Open Pleurae | Experimental | Bilateral open pleurae and usage of right pulmonary vein drainage |
|
| Right pleura open | Active Comparator | Opening of right pleura and usage of left ventricular apical drainage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Open Pleurae | Procedure | Both pleurae are opened Right pulmonary vein drainage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bansi Koul, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Department, Skane University Hospital | Lund | Lund, Skåne | 221 85 | Sweden |
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Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral Open Pleurae | Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage |
| FG001 | Right Pleura Open | Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Open Pleurae | Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage |
| BG001 | Right Pleura Open |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | gaseous cerebral microemboli | Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes |
|
Adverse event data were collected during the inpatient care period after surgery, approximately 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilateral Open Pleurae | Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological deficit | Nervous system disorders | SNOMED CT | Systematic Assessment | Any type of postoperative transient or permanent neurological dysfunction detected at routine bedside investigation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maya Landenhed Smith | Department of Cardiothoracic Surgery, Lund University | +4646173639 | maya.landenhed_smith@med.lu.se |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Right Pleura Open | Procedure | Right pleura open Left ventricular apical drainage |
|
| 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. | 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. | 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 |
Opening of right pleura and usage of left ventricular apical drainage.
Right Pleura Open: Right pleura open Left ventricular apical drainage
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body surface area | Median | Inter-Quartile Range | m^2 |
|
Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage |
| OG001 | Right Pleura Open | Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage |
|
|
|
| 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. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Median | Inter-Quartile Range | gaseous cerebral microemboli | 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. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Median | Inter-Quartile Range | gaseous cerebral microemboli | 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. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Count of Participants | Participants | 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. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Count of Participants | Participants | 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. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Count of Participants | Participants | 7-10 minutes after finished de-airing |
|
|
|
| Secondary | Duration of the De-airing Procedure | Duration of the de-airing procedure counted in minutes. | Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent. | Posted | Median | Inter-Quartile Range | minutes | Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Right Pleura Open | Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage | 0 | 10 | 0 | 10 | 1 | 10 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |