N/A
N=20
Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing
Brain Ischemia · Reduction of Cerebral Air Emboli
Bottom Line
View on ClinicalTrials.gov: NCT02119871 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery — 46; 32 gaseous cerebral microemboli — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilateral Open Pleurae (Procedure); Right Pleura Open (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lund University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
30; 34 | 1 |
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
30; 34 | 1 |
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
30; 34 | 1 |
| PRIMARY Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| PRIMARY Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| PRIMARY Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| SECONDARY Duration of the De-airing Procedure |
8; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Aortic valve pathology requiring surgery.
Exclusion Criteria
- Prior thoracic surgery,
- Severe chronic obstructive pulmonary disease and/or
- Emphysema.
Data sourced from ClinicalTrials.gov (NCT02119871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.