The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperoxia
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Telephonic-MoCA (t-MoCA)
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Shahzad Shaefi
Anesthesiologist
Beth Israel Deaconess Medical Center
Eligibility 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
Outcomes
Primary Outcomes
Telephonic-MoCA (t-MoCA)
Time Frame: Change from baseline tMoCA score through 6 months
t-MoCA will be performed baseline, daily starting POD#1 as well as at 1, 3 and 6 months post-operatively. In previous studies, testing through month 6, has been shown to accurately reflect more longitudinal follow-up. t-MoCA results are on a 22 point scale and will be used as a marker for cognitive function and has been validated. Blinded study staff trained in administering the assessments will collect the data.
Secondary Outcomes
- Days of mechanical ventilation(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Confusion Assessment Method for the ICU(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Length of stay in hospital(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Patient mortality(30 days and 6 months post-operatively)
- Time to extubation(Post-operative day 1 through discharge from hospital)
- Biomarkers of oxidative stress, IL-6, IL-8 and others(Intraoperatively at cardiopulmonary bypass (CPB))