Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/1/2019 |
| Start Date: | July 2015 |
| End Date: | November 1, 2019 |
The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
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.
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.
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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Shahzad Shaefi, MD
Phone: 617-667-1843
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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