Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Criteria:

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


NCT ID:

NCT02591589


Primary Contact:

Principal Investigator
Shahzad Shaefi, MD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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