Clinical Trial: Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations

Brief Summary: Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.

Detailed Summary:

Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).

Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.

Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).

Sponsor: Meshalkin Research Institute of Pathology of Circulation

Current Primary Outcome: postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: hospital mortality [ Time Frame: 14 days ]

Original Secondary Outcome: Same as current

Information By: Meshalkin Research Institute of Pathology of Circulation

Dates:
Date Received: December 16, 2014
Date Started: September 2014
Date Completion: September 2017
Last Updated: March 19, 2016
Last Verified: March 2016