Clinical Trial: Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.

Brief Summary: To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral pulmonary collapse for cardiac de-airing in open left-sided heart surgery.

Detailed Summary: Effective removal of air from the heart before termination of cardiopulmonary bypass (CPB) is vital in open left heart surgery. Bilateral collapse of the lungs during cardiopulmonary bypass decreases the duration of the de-airing procedure, decreases residual air emboli monitored on Trans-esophageal Echocardiography (TEE) and decreases gaseous cerebral microemboli (MES) monitored by Trans-cranial Echo-Doppler (TCD) when compared to expanded lungs during (CPB). Induced pulmonary collapse by opening of the pleura and disconnection of the patient from the ventilator during CPB decreases the amount of air that can enter the pulmonary veins. Not all surgeons wish to induce lung collapse from fraught that it might lead to pulmonary ischemia or infection. It is unknown whether collapse of only the right lung is as effective as collapse of both lungs.
Sponsor: Lund University

Current Primary Outcome:

• Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery [ Time Frame: Time from the release of the aortic crossclamp to cardiac ejection, 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 the left middle cerebral artery will be reported.
• Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery [ Time Frame: Time from cardiac ejection to finished de-airing, an average on 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 the left middle cerebral artery will be reported.
• Quantitative Assessment of Air Embolism to the Brain after Completion of Open Left Heart Surgery [ Time Frame: 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 the left middle cerebral artery will be reported.
• Number of Participants With <=Grade I air Emboli as Assessed by Trans-es
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: Duration of the De-airing Procedure [ Time Frame: Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes. ]

  Duration of the de-airing procedure counted in minutes.
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Lund University
  

  Dates:
  Date Received: April 17, 2014
  Date Started: January 2014
  Date Completion:
  Last Updated: June 21, 2014
  Last Verified: June 2014