Trial Outcomes & Findings for Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing (NCT NCT02119871)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes

Results posted on

2018-01-29

Participant Flow

Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.

Participant milestones

Participant milestones
Measure	Bilateral Open Pleurae Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Right Pleura Open Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Open Pleurae n=10 Participants Bilateral open pleurae and usage of right pulmonary vein drainage Bilateral Open Pleurae: Both pleurae are opened Right pulmonary vein drainage	Right Pleura Open n=10 Participants Opening of right pleura and usage of left ventricular apical drainage. Right Pleura Open: Right pleura open Left ventricular apical drainage	Total n=20 Participants Total of all reporting groups
Age, Continuous	69 years n=10 Participants	71 years n=10 Participants	70 years n=20 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	4 Participants n=10 Participants	7 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	6 Participants n=10 Participants	13 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants
Body surface area	1.97 m^2 n=10 Participants	1.93 m^2 n=10 Participants	1.97 m^2 n=20 Participants

PRIMARY outcome

Timeframe: 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.

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.