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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.
Patients planned for open left heart surgery, mainly aortic valve replacement, will be included in the study. Patients with aortic valve replacement and concomitant coronary artery bypass with vein grafts only can also be included.
Exclusion criteria are; significant chronic obstructive pulmonary disease/emphysema, significant (>50%)carotid artery disease, need of concomitant internal mammary harvesting, prior cardiac or pulmonary surgery, pulmonary adhesions preventing pulmonary collapse, previous radiation to the chest and prior severe chest trauma. Intraoperative exclusion criteria are; failure to obtain adequate bilateral Trans-cranial Echo-Doppler signals from the medial cerebral arteries, finding of adherent pleurae and accidental opening of the pleurae.
Twenty patients will be randomized to two groups:
Group I: Intact pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass (CPB), followed by staged filling of the heart.
Group II: Open pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass to ensure bilateral pulmonary collapse followed by conventional filling of the heart.
Data will be compared to a third historical control group, consisting of ten patients with open pleurae with the ventilator disconnected followed by staged filling of the heart.
Primary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open pleurae & conventional filling of heart | Experimental | In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral pulmonary 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. |
|
| Intact pleurae & staged filling of heart | Experimental | In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart procedure, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open pleurae & conventional filling of heart | Procedure | 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-esophageal echocardiography, the patient is weaned from cardiopulmonary bypass. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes |
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Time from cardiac ejection to finished de-airing, an average of 5-10 minutes |
| Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Period of ten minutes after finished de-airing |
| Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bansi Koul, MD, PhD | Cardiothoracic Surgery, Skåne University Hospital Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University | Lund | Skåne County | 22350 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19577073 | Background | Al-Rashidi F, Blomquist S, Hoglund P, Meurling C, Roijer A, Koul B. A new de-airing technique that reduces systemic microemboli during open surgery: a prospective controlled study. J Thorac Cardiovasc Surg. 2009 Jul;138(1):157-62. doi: 10.1016/j.jtcvs.2009.02.037. | |
| 20817209 | Background | Al-Rashidi F, Landenhed M, Blomquist S, Hoglund P, Karlsson PA, Pierre L, Koul B. Comparison of the effectiveness and safety of a new de-airing technique with a standardized carbon dioxide insufflation technique in open left heart surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2011 May;141(5):1128-33. doi: 10.1016/j.jtcvs.2010.07.013. Epub 2010 Sep 3. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Only participants that did not fulfill intraoperative exclusion criteria continued throughout the study according to the study protocol and were included in baseline data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Posted | Median | Inter-Quartile Range | Air microemboli | Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebral infarction | Nervous system disorders | SNOMED CT | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebral infarction | Nervous system disorders | SNOMED CT | Non-systematic Assessment | Confirmed by cerebral CT scan on postoperative day 2. |
This study is a small single center study. Though randomized and controlled, the surgeon and anesthesiologist were not blinded to which arm a participant belonged to during the course of surgery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bansi Koul | Lunds University | +4646171649 | bansi.koul@skane.se |
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| Intact pleurae & staged filling of heart | Procedure | 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 Echocardiography. Thereafter the lungs are ventilated with 50% of the estimated lung minute volume and 5 cm positive end-expiratory pressure and cardiac filling and de-airing continued. If no air is seen in the left heart full ventilation is started and the patient is weaned from cardiopulmonary bypass. |
|
|
| 0-3 minutes after finished de-airing |
| Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. | 3-6 minutes after finished de-airing |
| Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. | 6-10 minutes after finished de-airing |
| Duration of the De-airing Procedure | 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. | Time from release of aortic crossclamp to finished de-airing |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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 |
|
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| Primary | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Posted | Median | Inter-Quartile Range | Air microemboli | Time from cardiac ejection to finished de-airing, an average of 5-10 minutes |
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| Primary | Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery | 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. | Posted | Median | Inter-Quartile Range | Air microemboli | Period of ten minutes after finished de-airing |
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| Primary | Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. | Posted | Number | Participants | 0-3 minutes after finished de-airing |
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| Primary | Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. | Posted | Number | Participants | 3-6 minutes after finished de-airing |
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| Primary | Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) 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. | Posted | Number | Participants | 6-10 minutes after finished de-airing |
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| Primary | Duration of the De-airing Procedure | 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. | Posted | Median | Inter-Quartile Range | Minutes | Time from release of aortic crossclamp to finished de-airing |
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| 1 |
| 10 |
| 1 |
| 10 |
| EG001 | 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 | 0 | 10 | 0 | 10 |
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