Delirium, Hyperoxia, Normoxic
Conditions
Keywords
Hyperoxia, Delirium, Normoxic, t-MoCA
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.
Interventions
OTHERNormoxic oxygenation
FiO2 set at 0.35 to maintain PaO2 \> 70 mmHg or oxygen saturation greater than or equal to 92%.
OTHERHyperoxic oxygenation
FiO2 set at 1.0 throughout the procedure
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Telephonic-MoCA (t-MoCA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Days of mechanical ventilation | 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) | — |
| Confusion Assessment Method for the ICU | Post-operative day 1 through discharge from hospital (3-5 days on average) | CAM and CAM-ICU as a marker of delirium post-operatively will be administered and measured at the same time as the t-MoCA. This is a validated test to measure delirium. There is much data to support an increased reduction in cognitive ability in patients exhibiting post-operative delirium. |
| Patient mortality | 30 days and 6 months post-operatively | — |
| Biomarkers of oxidative stress, IL-6, IL-8 and others | Intraoperatively at cardiopulmonary bypass (CPB) | — |
| Time to extubation | Post-operative day 1 through discharge from hospital | — |
Countries
United States
Outcome results
None listed