NCT01432184

Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery

Perioperative Interventions to Optimize Cerebral Oxygen Saturation (rSO2) in High-risk Patients Undergoing Cardiac Surgery Should Have a Beneficial Systemic Effect for Enhancing Global Tissue Perfusion and Improve Outcomes.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Using the brain and the heart as index organs, perioperative interventions to optimize cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac surgery should have a beneficial systemic effect for enhancing global tissue perfusion and improve outcomes.

Detailed description

The proportion of high-risk patients requiring cardiac surgery and of high-risk cardiac surgeries is increasing. These populations of patients are at increased risk of perioperative morbidity and mortality. Transesophageal echocardiography (TEE) evaluation in cardiac surgery has been shown to impact on the perioperative management of patients and to improve outcomes. Near infrared-reflectance spectroscopy (NIRS) is a technique that has been employed since the mid-1970's and that can be used as a non-invasive and continuous monitor of the balance between cerebral oxygen delivery and consumption. Two recent randomized trials have shown an association between correction of cerebral desaturation and shorter recovery room and hospital stay in non-cardiac surgery, and with a decrease in major organ dysfunction and in intensive care length of stay after coronary artery bypass. By combining NIRS and TEE in high-risk patients, optimal tissue perfusion could be achieved and perioperative morbidity and mortality could be reduced.

Conditions

• Cerebral Hypoxia

Interventions

Type	Name	Description
PROCEDURE	strategies to reverse decrease in rSO2	an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-07-01
• Completion: 2013-10-01
• First posted: 2011-09-12
• Last updated: 2015-10-20

Locations

1 site across 1 country: Canada