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Completed

NCT Number: NCT01432184

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

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.

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Key information

Conditions

Cerebral Hypoxia Brain Diseases Central Nervous System Diseases Hypoxia Hypoxia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

strategies to reverse decrease in rSO2

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. First 30 days post-operative outcomes

    Time frame: 30 days

    • readmission to hospital within 30 days
    • death

  2. ICU data

    Time frame: Up to 48 hours

    • ICU admission and discharge times
    • tracheal extubation time in hours

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Université de Montréal

Registry information

Official study 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.

Acronym: Tête-à-coeur

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Sep 12, 2011
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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