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

October 16, 2015 updated by: Alain Deschamps, Montreal Heart Institute

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.
Time Frame: 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.
Up to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First 30 days post-operative outcomes
Time Frame: 30 days
  • readmission to hospital within 30 days
  • death
30 days
ICU data
Time Frame: Up to 48 hours
  • ICU admission and discharge times
  • tracheal extubation time in hours
Up to 48 hours
First 24 hours complications
Time Frame: 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
24 hours
Post-operative complications
Time Frame: 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
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Université de Montréal

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 08-1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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