Trial Outcomes & Findings for Factors Responsible for the Effectiveness of the Lund De-airing Technique (NCT NCT01757704)

NCT ID: NCT01757704

Last Updated: 2014-02-10

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 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 10-15 minutes
• Results posted on: 2014-02-10

Participant Flow

Patients who were scheduled at the Department of Cardiothoracic Surgery, anesteshia and intensive care at Skane University Hospital for elective open left sided heart surgery were eligible for inclusion. Recruitment started in september 2012 and ended in june 2013.

In this study a total of 4 participants did not complete due to intraoperative exclusion criteria only possible to detect after start of the surgical procedure (adherant lung, accidental pleural opening, TCD signal insufficient). Enrollment and randomization continued until 10 patients in each arm were included and satisfied protocol criteria.

Participant milestones

Measure	Intact Pleurae & Staged Filling of Heart In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Overall Study STARTED	11	13
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Intact Pleurae & Staged Filling of Heart In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Overall Study Protocol Violation	1	3

Baseline Characteristics

Factors Responsible for the Effectiveness of the Lund De-airing Technique

Baseline characteristics by cohort

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag	Total n=20 Participants Total of all reporting groups
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Sweden	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	69.2 years STANDARD_DEVIATION 12.5 • n=5 Participants	71.1 years STANDARD_DEVIATION 11.5 • n=7 Participants	70.2 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 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 left middle cerebral artery will be reported.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	49 Air microemboli Interval 44.0 to 113.0	46 Air microemboli Interval 43.0 to 69.0

PRIMARY outcome

Timeframe: Time from cardiac ejection to finished de-airing, 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 left middle cerebral artery will be reported.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	71 Air microemboli Interval 32.0 to 281.0	28 Air microemboli Interval 14.0 to 41.0

PRIMARY outcome

Timeframe: Period of ten minutes after finished de-airing

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 left middle cerebral artery will be reported.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery	65 Air microemboli Interval 38.0 to 210.0	9 Air microemboli Interval 6.0 to 36.0

PRIMARY outcome

Timeframe: 0-3 minutes after finished de-airing

The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.	3 Participants	10 Participants

PRIMARY outcome

Timeframe: 3-6 minutes after finished de-airing

The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.	6 Participants	10 Participants

PRIMARY outcome

Timeframe: 6-10 minutes after finished de-airing

The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.	9 Participants	10 Participants

PRIMARY outcome

Timeframe: Time from release of aortic crossclamp to finished de-airing

The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.

Outcome measures

Measure	Intact Pleurae & Staged Filling of Heart n=10 Participants In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 Participants In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Duration of the De-airing Procedure	14 Minutes Interval 10.0 to 20.0	8.5 Minutes Interval 6.0 to 12.0

Adverse Events

Intact Pleurae & Staged Filling of Heart

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Open Pleurae & Conventional Filling of Heart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intact Pleurae & Staged Filling of Heart n=10 participants at risk In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 participants at risk In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Nervous system disorders cerebral infarction	10.0% 1/10 • Number of events 1 • Postoperative hospital stay, an average of 7 Days. Participants medical charts were studied to find reported signs of postoperative neurological dysfunction that included clinical signs of stroke or transient neurological deficit. Transient neurological dysfunction was defined as severe confusion, agitation or hallucinations.	0.00% 0/10 • Postoperative hospital stay, an average of 7 Days. Participants medical charts were studied to find reported signs of postoperative neurological dysfunction that included clinical signs of stroke or transient neurological deficit. Transient neurological dysfunction was defined as severe confusion, agitation or hallucinations.

Other adverse events

Measure	Intact Pleurae & Staged Filling of Heart n=10 participants at risk In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar	Open Pleurae & Conventional Filling of Heart n=10 participants at risk In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag
Nervous system disorders cerebral infarction	10.0% 1/10 • Number of events 1 • Postoperative hospital stay, an average of 7 Days. Participants medical charts were studied to find reported signs of postoperative neurological dysfunction that included clinical signs of stroke or transient neurological deficit. Transient neurological dysfunction was defined as severe confusion, agitation or hallucinations.	0.00% 0/10 • Postoperative hospital stay, an average of 7 Days. Participants medical charts were studied to find reported signs of postoperative neurological dysfunction that included clinical signs of stroke or transient neurological deficit. Transient neurological dysfunction was defined as severe confusion, agitation or hallucinations.

Additional Information

Dr. Bansi Koul

Lunds University

Phone: +4646171649

Email: bansi.koul@skane.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place