Clinical Trial: CO2 Versus Lund De-airing Technique in Heart Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy
Brief Summary:
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
Detailed Summary:
Study design:
Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be blinded to the de-airing technique used (the recorded videos will be analyzed at the end of the study). The TCD monitoring will be done by on-line automatic recording of the micro embolic signals (MES) from the right and or left middle cerebral arteries and performed by single surgeon. The CO2 insufflation of the operating field will be performed according to manufacturer's guide lines. During entire study course one type of extracorporeal perfusion system will be used.The study will be registered in the international database. A prior approval will be sought from the hospital ethical committee for the study.
Patient selection:
Patients planned for aortic valve/root replacement or repair will be selected for the study
Exclusion criteria:
Patients with known: a) chronic obstructive pulmonary disease, b) emphysema, c) previous thoracic or cardiac surgery, d) history of CVA or stroke and e) evidence of intraoperative pleural adhesions will be excluded from the study. Patients requiring internal mammary artery coronary bypass will also be excluded.
Patient consent:
A written consent previously approved by the hospital ethical committee will be obtained from all patients before they are enrolled in the study (enclosure 3).
Original Primary Outcome: No. of air microemboli registered on-line over middle cerebral artery [ Time Frame: During cardiac de-airing and 10 minutes directly after ]
Current Secondary Outcome:
- Total Time Required for De-airing [ Time Frame: After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes ]The total de-airing time as measured in minutes.
- De-airing Time Before Cardiac Ejection [ Time Frame: Measured during intraoperative course ]Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).
- De-airing Time After Cardiac Ejection [ Time Frame: During de-airing procedure ]The duration in minutes of the period after cardiac ejection to finished de-airing procedure.
- Oxygenator Gas Flow at 45 Minutes of CPB [ Time Frame: Intraoperative ]The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.
- pH at 45 Min of CPB [ Time Frame: Intraoperative ]pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups
Original Secondary Outcome: Total Time Required for De-airing [ Time Frame: After completion of heart surgery and before de-airing is complete ]
Information By: Lund University
Dates:
Date Received: July 7, 2009
Date Started: June 2009
Date Completion:
Last Updated: October 7, 2013
Last Verified: October 2013