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Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

NCT02591589 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Shahzad Shaefi, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-01-17
Completion
2021-03-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591589 on ClinicalTrials.gov