NCT02340741

Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Air Embolism
• Neurological Damage

Interventions

Type	Name	Description
PROCEDURE	conventional prophylaxis of aeroembolism	167 patients will be enrolled. Will perform standard way of aeroembolism prevention
PROCEDURE	conventional prophylaxis plus CO2 insufflation	167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide
PROCEDURE	cardiac surgery with opening of heart chambers	Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-01-19
• Last updated: 2016-03-22

Locations

1 site across 1 country: Russia