Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery (Tête-à-coeur)

University of Montreal

Status: Completed

Conditions: Cerebral Hypoxia

Treatments: Procedure: strategies to reverse decrease in rSO2

Study type: Interventional

Funder types: Other

Identifiers

NCT01432184

ICM 08-1009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Procedure: strategies to reverse decrease in rSO2

Control

No Intervention group

Description:

the cerebral oxymetry screen will be blinded and changes in NIRS values will be unknown to the anesthesiologist. The management of the case will proceed as per normal local practice. The screen will remain blinded in the ICU and the intensivist will not see the values.