N/A
N=20
CO2 Versus Lund De-airing Technique in Heart Surgery
Aortic Valve Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00934596 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). — 41; 118 Air Microemboli — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lund de-airing technique (Procedure); carbon-dioxide insufflation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lund University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). |
5; 46 | <0.001 sig |
| PRIMARY Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). |
5; 46 | <0.001 sig |
| PRIMARY Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). |
5; 46 | <0.001 sig |
| PRIMARY Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE). |
9; 7 | — |
| PRIMARY Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE). |
9; 7 | — |
| PRIMARY Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE). |
9; 7 | — |
| SECONDARY Total Time Required for De-airing |
9; 15 | — |
| SECONDARY De-airing Time Before Cardiac Ejection |
6; 7 | — |
| SECONDARY De-airing Time After Cardiac Ejection |
3; 5 | — |
| SECONDARY Oxygenator Gas Flow at 45 Minutes of CPB |
0.65; 2.2 | — |
| SECONDARY pH at 45 Min of CPB |
7.30; 7.35 | — |
Summary
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
Eligibility Criteria
Inclusion Criteria
- Patients planned for aortic valve/root replacement or repair will be selected for the study
Exclusion Criteria
Patients with known
- chronic obstructive pulmonary disease,
- emphysema,
- previous thoracic or cardiac surgery,
- history of CVA or stroke and
- evidence of intraoperative pleural adhesions will be excluded from the study.
- Patients requiring internal mammary artery coronary bypass will also be excluded.
Data sourced from ClinicalTrials.gov (NCT00934596). 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.