Brain Ischemia, Reduction of Cerebral Air Emboli
Conditions
Keywords
Cerebral air emboli, heart surgery
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.
Interventions
PROCEDUREBilateral Open Pleurae
Both pleurae are opened Right pulmonary vein drainage
PROCEDURERight Pleura Open
Right pleura open Left ventricular apical drainage
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Aortic valve pathology requiring surgery.
Exclusion criteria
* Prior thoracic surgery, * Severe chronic obstructive pulmonary disease and/or * Emphysema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Participant flow
Recruitment details
Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Open Pleurae Bilateral open pleurae and usage of right pulmonary vein drainage
Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage | 10 |
| Right Pleura Open Opening of right pleura and usage of left ventricular apical drainage.
Right Pleura Open: Right pleura open Left ventricular apical drainage | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Bilateral Open Pleurae | Right Pleura Open | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 71 years | 70 years |
| Body surface area | 1.97 m^2 | 1.93 m^2 | 1.97 m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Sweden | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 0-3 minutes after finished de-airing
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bilateral Open Pleurae | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 8 Participants |
| Right Pleura Open | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 9 Participants |
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.
Time frame: 3-6 minutes after finished de-airing
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bilateral Open Pleurae | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 9 Participants |
| Right Pleura Open | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 10 Participants |
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.
Time frame: 7-10 minutes after finished de-airing
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bilateral Open Pleurae | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 9 Participants |
| Right Pleura Open | Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. | 10 Participants |
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.
Time frame: Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Bilateral Open Pleurae | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 46 gaseous cerebral microemboli |
| Right Pleura Open | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 32 gaseous cerebral microemboli |
p-value: 1Wilcoxon (Mann-Whitney)
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.
Time frame: Time from cardiac ejection to finished de-airing, an average on 5-10 minutes
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bilateral Open Pleurae | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 31 gaseous cerebral microemboli |
| Right Pleura Open | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 41 gaseous cerebral microemboli |
p-value: 0.656Wilcoxon (Mann-Whitney)
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.
Time frame: Period of ten minutes after finished de-airing
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bilateral Open Pleurae | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 30 gaseous cerebral microemboli |
| Right Pleura Open | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 34 gaseous cerebral microemboli |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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.
Population: Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bilateral Open Pleurae | Duration of the De-airing Procedure | 8 minutes |
| Right Pleura Open | Duration of the De-airing Procedure | 10 minutes |