Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery (NCT02591589) | Clinical Trial Compass
UnknownNot Applicable
Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
United States100 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Telephonic-MoCA (t-MoCA)
Timeframe: Change from baseline tMoCA score through 6 months