Factors Responsible for the Effectiveness of the Lund De-airing Technique
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Purpose
The Lund de-airing technique is employed for cardiac de-airing after 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.
| Condition | Intervention |
|---|---|
|
Complication of Surgical Procedure |
Procedure: Open pleura & regular ventilation Procedure: Intact pleura & staged ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Factors Responsible for the Effectiveness of the Lund Technique for De-airing Following Open Left Heart Surgery. |
- Quantitative assessment of air embolism to the brain after completion of open left heart surgery [ Time Frame: During and 10 minutes after de-airing has been completed ] [ Designated as safety issue: Yes ]In patients undergoing open left heart surgery, brain emboli will be assessed quantitatively by intraoperative trans-esophageal echocardiography and trans-cranial ultrasonography during de-airing and 10 minutes after completion of the de-airing.
- To estimate the time it requires to de-air the heart completely. [ Time Frame: From release of aortic clamp to end of deairing ] [ Designated as safety issue: Yes ]Completion of cardiac de-airing will be dictated by intraoperative trans-esophageal echocardiography and as defined by absence of air emboli in the left atrium, left ventricle and aorta over a period of one minute after completion of cardio-pulmonary bypass and with patient fully ventilated.
- Post-operative time on ventilator [ Time Frame: Intensive Care stay ] [ Designated as safety issue: Yes ]Postoperative time on ventilator may reflect indirectly the efficacy of intraoperative de-airing
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open pleura & regular ventilation
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 CPB the residual air in the left heart will be quantitatively assessed by TEE and trans-cranial ultrasonography over a period of 10 minutes.
|
Procedure: Open pleura & regular ventilation
After completion of the left heart surgery, the heart will be actively filled from CPB and lung fully ventilated with positive end-expiratory pressure to flush all air trapped in the left heart. Thereafter heart will be reperfused by the CPB.
Other Names:
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Experimental: Intact pleura & staged ventilation
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 CPB the residual air in the left heart will be quantitatively assessed by TEE and trans-cranial ultrasonography over a period of 10 minutes.
|
Procedure: Intact pleura & staged ventilation
After the end of the left heart surgery,gradual filling of the heart from heart-lung machine and spontaneous cardiac contractions fill the lungs with blood till no more air is seen in left heart on TEE. Thereafter the lungs are ventilated 50% and 5 cm PEEP and cardiac filling and de-airing continued. If no air is seen in left heart full ventilation is started and cardiac filling continued and patient weaned from CPB
Other Names:
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Detailed Description:
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 COPD/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.
Twenty patients will be randomized to two groups:
Group I: Intact pleura bilaterally, disconnection of the ventilator during CPB, followed by staged filling of the heart.
Group II: Open pleura bilaterally, disconnection of the ventilator during CPB 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 pleura bilaterally with ventilator disconnected followed by staged filling of the heart.
Main outcomes: Residual air emboli from the left heart will be qualitatively monitored grossly by transesophageal echocardiography. Microembolic signals as monitored by transcranial Doppler sonography of the middle cerebral arteries will quantitatively assess the number of emboli to the brain.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Bansi Koul, MD, PhD | bansi.koul@skane.se | |
| Contact: Maya Landenhed, MD | maya.landenhed@med.lu.se |
| Sweden | |
| Lund University | Recruiting |
| Lund, Skåne, Sweden, 22350 | |
| Contact: Bansi Koul, MD, PhD bansi.koul@skane.se | |
| Contact: Maya Landenhed, MD maya.landenhed@med.lu.se | |
| Principal Investigator: Bansi Koul, MD, PhD | |
| Principal Investigator: | Bansi Koul, MD, PhD | Cardiothoracic Surgery, Skåne University Hospital Lund, Sweden |
More Information
Publications:
| Responsible Party: | Bansi Lal Koul, Med dr. Ph. D., Lund University |
| ClinicalTrials.gov Identifier: | NCT01757704 History of Changes |
| Other Study ID Numbers: | BKML-003 |
| Study First Received: | September 22, 2012 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Sweden: Swedish Data Inspection Board Sweden: Swedish National Council on Medical Ethics Sweden: Swedish Research Council |
Keywords provided by Lund University:
|
Cardiac de-airing Air emboli Transcranial Doppler Intraoperative echocardiography |
ClinicalTrials.gov processed this record on May 23, 2013