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

Sponsor

Montreal Heart Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01432184

Collaborator

Université de Montréal (Other)

200

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Hypoxia	Procedure: strategies to reverse decrease in rSO2	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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.

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention 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.	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. Other Names: Cerebral Oxymetry decrease
No Intervention: Control 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.

Arm

Intervention/Treatment

Active Comparator: Intervention

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.

Procedure: strategies to reverse decrease in rSO2

Other Names:

Cerebral Oxymetry decrease

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

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

First 30 days post-operative outcomes [30 days]
readmission to hospital within 30 days death
ICU data [Up to 48 hours]
ICU admission and discharge times tracheal extubation time in hours
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8

Sponsors and Collaborators

Montreal Heart Institute
Université de Montréal

Investigators

Principal Investigator: Alain Deschamps, MD, FRCPC, Montreal Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Alain Deschamps, PhD, MD, FRCPC,, Montreal Heart Institute

ClinicalTrials.gov Identifier:

NCT01432184

Other Study ID Numbers:

ICM 08-1009

First Posted:

Sep 12, 2011

Last Update Posted:

Oct 20, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Alain Deschamps, PhD, MD, FRCPC,, Montreal Heart Institute

cerebral

hypoxia

Additional relevant MeSH terms:

Hypoxia, Brain

Hypoxia

Study Results

No Results Posted as of Oct 20, 2015