Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

September 21, 2020 updated by: Shahzad Shaefi, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normoxic group
To standardize key aspects of ventilator support, tidal volume will be set to 6-8ml/kg and PEEP levels will be set to 0-5cm H2O, allowing flexibility for provider preference. For normoxic oxygenation FiO2 will be set at 0.35 (35%) ideally to maintain PaO2 above 70mmHg (or saturations greater than or equal to 92%), and titrated up if need be to prevent potentially injurious hypoxemia (saturations below 92%). During cardiopulmonary bypass, blended air/ oxygen mixture will be titrated to arterial blood gas analysis with maintenance of PaO2 between 100mmHg and 150mmHg.
Other: Normoxic oxygenation
FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%.
Active Comparator: Hyperoxic group
To standardize key aspects of ventilator support, tidal volume will be set to 6-8ml/kg and PEEP levels will be set to 0-5cm H2O, allowing flexibility for provider preference. For hyperoxic oxygenation FiO2 will be set at 1.0 (100%) throughout the intraoperative period, including cardiopulmonary bypass.
Other: Hyperoxic oxygenation
FiO2 set at 1.0 throughout the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telephonic-MoCA (t-MoCA)
Time Frame: Change from baseline tMoCA score through 6 months
t-MoCA will be performed baseline, daily starting POD#1 as well as at 1, 3 and 6 months post-operatively. In previous studies, testing through month 6, has been shown to accurately reflect more longitudinal follow-up. t-MoCA results are on a 22 point scale and will be used as a marker for cognitive function and has been validated. Blinded study staff trained in administering the assessments will collect the data.
Change from baseline tMoCA score through 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confusion Assessment Method for the ICU
Time Frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
CAM and CAM-ICU as a marker of delirium post-operatively will be administered and measured at the same time as the t-MoCA. This is a validated test to measure delirium. There is much data to support an increased reduction in cognitive ability in patients exhibiting post-operative delirium.
Post-operative day 1 through discharge from hospital (3-5 days on average)
Days of mechanical ventilation
Time Frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
Post-operative day 1 through discharge from hospital (3-5 days on average)
Length of stay in hospital
Time Frame: Post-operative day 1 through discharge from hospital (3-5 days on average)
Post-operative day 1 through discharge from hospital (3-5 days on average)
Time to extubation
Time Frame: Post-operative day 1 through discharge from hospital
Post-operative day 1 through discharge from hospital
Patient mortality
Time Frame: 30 days and 6 months post-operatively
30 days and 6 months post-operatively
Biomarkers of oxidative stress, IL-6, IL-8 and others
Time Frame: Intraoperatively at cardiopulmonary bypass (CPB)
Intraoperatively at cardiopulmonary bypass (CPB)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Shahzad Shaefi, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 17, 2018

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P000398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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