Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

Beth Israel Deaconess Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Hyperoxia Normoxic Delirium

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Telephonic-MoCA (t-MoCA)

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.

Time frame: Change from baseline tMoCA score through 6 months

Secondary Outcomes

Confusion Assessment Method for the ICU

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.

Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)

Days of mechanical ventilation

Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)

Length of stay in hospital

Time frame: Post-operative day 1 through discharge from hospital (3-5 days on average)

Time to extubation

Time frame: Post-operative day 1 through discharge from hospital

Patient mortality

Time frame: 30 days and 6 months post-operatively

Biomarkers of oxidative stress, IL-6, IL-8 and others

Time frame: Intraoperatively at cardiopulmonary bypass (CPB)

Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes