Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
Status unconfirmed · Not applicable
Conditions studied: Hyperoxia, Normoxic, Delirium
In brief
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.
Key facts
- Study ID
- NCT02591589
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 100
- Starts
- 2015-07-01
- Expected to finish
- 2021-03-01
- Last updated by the study team
- 2020-09-23
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females aged 65 years and older
- Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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