UnknownNot Applicable

Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

United States100 participantsStarted 2015-07

Plain-language summary

This is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females aged 65 years and older * Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only Exclusion Criteria: * Off-pump or any other procedure in addition to CABG * Emergent procedure * One-lung ventilation * Non-English speaking * Baseline tMoCA score \<10 * Preoperative inotrope use * Preoperative vasopressor use * Intra-aortic balloon counterpulsation * Mechanical circulatory support (Intra-aortic balloon pump (IABP)/ Ventricular assisted devices (VAD)/Extracorporeal membrane oxygenation (ECMO)) * Active cardiac ischemia * Acute decompensated arrhythmia * O2 sat \< 90% on supplemental oxygen * Use of continuous vasopressor or inotrope infusion medications * Significant physician or nurse concern Cessation Criteria * Development of significant intraoperative hemodynamic compromise as a result of cardiac surgery * Oxygen desaturation \<90% for \> 3 min * Significant physician or nurse concern

What they're measuring

Telephonic-MoCA (t-MoCA)

Timeframe: Change from baseline tMoCA score through 6 months

Trial details

NCT IDNCT02591589

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-17