NCT02591589

Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperoxia
• Normoxic
• Delirium

Interventions

Type	Name	Description
OTHER	Normoxic oxygenation	FiO2 set at 0.35 to maintain PaO2 \> 70 mmHg or oxygen saturation greater than or equal to 92%.
OTHER	Hyperoxic oxygenation	FiO2 set at 1.0 throughout the procedure

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-01-17
• Completion: 2021-03-01
• First posted: 2015-10-29
• Last updated: 2020-09-23

Locations

1 site across 1 country: United States