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

Not Applicable

Completed

• Conditions: Cerebral Hypoxia
• Interventions: Procedure: strategies to reverse decrease in rSO2

• Registration Number: NCT01432184
• Lead Sponsor: Montreal Heart Institute

Brief 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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-07
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Study Completion: 2013-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with EUROSCORES ≥ 10.
• Planned complex surgery including more than one procedure, or redo procedures.
• Patient able to read and understand the consent form.
• Patients ≥ 18 years of age.

Exclusion Criteria

• High risk patients undergoing of off pump coronary artery bypass.
• Emergency surgeries less than 6 hours from diagnosis.
• Patient unable to read and understand the consent form.
• Patients with and IABP or a ventricular assist device
• Planned circulatory arrest
• Planned surgery of the descending aorta.
• Patients with acute endocarditis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.	Up to 12 hours	Consensus on the appropriate strategies to prevent and reverse cerebral oxygen desaturations remains controversial. In a recent study by Slater and al.12, randomization into an intervention group failed because anesthesiologists were unable to follow the protocol aimed at strategies to reverse decreases in rSO2. A group from the Montreal Heart Institute has developed a physiologically oriented algorithm to help with the task of reversing decreases in rSO2. The goal of the present study is therefore to confirm that this approach can be used with success by most institutions.

Secondary Outcome Measures

Name	Time	Method
First 24 hours complications	24 hours	* clinical stroke manifested as focal neurological deficit persisting 24hr and confirmed by brain computed tomography imaging; * prolonged ventilation defined as extubation at \> 24 h postoperatively; * new, persistent Q-wave myocardial infarction
First 30 days post-operative outcomes	30 days	* readmission to hospital within 30 days; * death
Post-operative complications	Up to 7 days	* renal failure as defined by the RIFLE criteria; * reoperation for any cause; * arrhythmia requiring treatment; * Hospital length of stay; * wound infection requiring specific antibiotic coverage
ICU data	Up to 48 hours	* ICU admission and discharge times; * tracheal extubation time in hours

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada