N/A
N=24
Factors Responsible for the Effectiveness of the Lund De-airing Technique
Complication of Surgical Procedure
Bottom Line
View on ClinicalTrials.gov: NCT01757704 ↗Enrolled (actual)
24
Serious AEs
5.0%
Results posted
Dec 2013
Primary outcome: Primary: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery — 49; 46 Air microemboli
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open pleurae & conventional filling of heart (Procedure); Intact pleurae & staged filling of heart (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lund University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
65; 9 | <0.01 sig |
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
65; 9 | <0.01 sig |
| PRIMARY Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery |
65; 9 | <0.01 sig |
| PRIMARY Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| PRIMARY Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| PRIMARY Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing. |
9; 10 | — |
| PRIMARY Duration of the De-airing Procedure |
14; 8.5 | — |
Summary
The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the CPB. The aim of this study is to analyze in a randomized manner two groups of patients to establish if one or both components are of primary importance for the effectiveness of the de-airing technique.
Eligibility Criteria
Inclusion Criteria
- Patients planned for aortic valve replacement with or without coronary vein bypass grafts
Exclusion Criteria
- Significant chronic obstructive pulmonary disease and emphysema
- Previous history of thoracic or cardiac surgery
- Patients requiring internal mammary artery harvesting
- Unilateral or bilateral pulmonary adhesions to chest wall
- Previous radiation to the chest
Intraoperative Exclusion Criteria:
- Inability to obtain adequate bilateral Trans-cranial Echo-doppler signals
- Adherent pleurae
- Accidental opening of the pleurae
Data sourced from ClinicalTrials.gov (NCT01757704). 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.