An interventional study of Bilateral Open Pleurae and Right Pleura Open in Brain Ischemia and Reduction of Cerebral Air Emboli, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Lund University · Not applicable, Interventional, and Prevention
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.
301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.
This study's enrollment of 20 is below the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral open pleurae and usage of right pulmonary vein drainage
Procedure: Bilateral Open Pleurae
Opening of right pleura and usage of left ventricular apical drainage.
Procedure: Right Pleura Open
Both pleurae are opened Right pulmonary vein drainage
Right pleura open Left ventricular apical drainage
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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7-10 minutes after finished de-airing
Duration of the De-airing Procedure
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.
Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.
| Milestone | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| gaseous cerebral microemboli | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 46 (21 to 107) | 32 (16 to 68) |
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.
| gaseous cerebral microemboli | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 31 (10 to 166) | 41 (27 to 55) |
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.
| gaseous cerebral microemboli | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 30 (9 to 75) | 34 (14 to 43) |
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.
| Participants | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 8 | 9 |
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.
| Participants | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 9 | 10 |
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.
| Participants | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 9 | 10 |
Duration of the de-airing procedure counted in minutes.
| minutes | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Duration of the De-airing Procedure | 8 (6 to 12) | 10 (7 to 11) |
Collected over Adverse event data were collected during the inpatient care period after surgery, approximately 1 week.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bilateral Open Pleurae | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Right Pleura Open | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Bilateral Open Pleurae | Right Pleura Open |
|---|---|---|
| Neurological deficitNervous system disorders | 1/10 | 1/10 |
Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Age, Continuous(years) | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Median | 69 (65 to 74) | 71 (64 to 79) | 70 (65 to 74) |
| Sex: Female, Male(Participants) | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 7 | 6 | 13 |
| Race and Ethnicity Not Collected(Participants) | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Sweden | 10 | 10 | 20 |
| Body surface area(m^2) | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Median | 1.97 (1.71 to 2.13) | 1.93 (1.79 to 2.11) | 1.97 (1.79 to 2.11) |
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