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

Primary Purpose

Cerebral Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
strategies to reverse decrease in rSO2
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Hypoxia focused on measuring cerebral, hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

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.
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
readmission to hospital within 30 days death
ICU data
ICU admission and discharge times tracheal extubation time in hours
First 24 hours complications
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
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

Full Information

First Posted
August 26, 2011
Last Updated
October 16, 2015
Sponsor
Montreal Heart Institute
Collaborators
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01432184
Brief Title
Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery
Acronym
Tête-à-coeur
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
Collaborators
Université de Montréal

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hypoxia
Keywords
cerebral, hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
strategies to reverse decrease in rSO2
Other Intervention Name(s)
Cerebral Oxymetry decrease
Intervention 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.
Primary Outcome Measure Information:
Title
Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.
Description
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.
Time Frame
Up to 12 hours
Secondary Outcome Measure Information:
Title
First 30 days post-operative outcomes
Description
readmission to hospital within 30 days death
Time Frame
30 days
Title
ICU data
Description
ICU admission and discharge times tracheal extubation time in hours
Time Frame
Up to 48 hours
Title
First 24 hours complications
Description
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
Time Frame
24 hours
Title
Post-operative complications
Description
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
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Deschamps, MD, FRCPC
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15625262
Citation
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PubMed Identifier
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
17179242
Citation
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PubMed Identifier
18270192
Citation
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PubMed Identifier
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Citation
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Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery

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