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Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

Primary Purpose

Hyperoxia, Normoxic, Delirium

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normoxic oxygenation
Hyperoxic oxygenation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperoxia focused on measuring Hyperoxia, Delirium, Normoxic, t-MoCA

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Normoxic group

Hyperoxic group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Telephonic-MoCA (t-MoCA)
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.

Secondary Outcome Measures

Confusion Assessment Method for the ICU
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.
Days of mechanical ventilation
Length of stay in hospital
Time to extubation
Patient mortality
Biomarkers of oxidative stress, IL-6, IL-8 and others

Full Information

First Posted
February 13, 2015
Last Updated
September 21, 2020
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02591589
Brief Title
Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery
Official Title
The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia, Normoxic, Delirium
Keywords
Hyperoxia, Delirium, Normoxic, t-MoCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normoxic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyperoxic group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Normoxic oxygenation
Intervention Description
FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%.
Intervention Type
Other
Intervention Name(s)
Hyperoxic oxygenation
Intervention Description
FiO2 set at 1.0 throughout the procedure
Primary Outcome Measure Information:
Title
Telephonic-MoCA (t-MoCA)
Description
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.
Time Frame
Change from baseline tMoCA score through 6 months
Secondary Outcome Measure Information:
Title
Confusion Assessment Method for the ICU
Description
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.
Time Frame
Post-operative day 1 through discharge from hospital (3-5 days on average)
Title
Days of mechanical ventilation
Time Frame
Post-operative day 1 through discharge from hospital (3-5 days on average)
Title
Length of stay in hospital
Time Frame
Post-operative day 1 through discharge from hospital (3-5 days on average)
Title
Time to extubation
Time Frame
Post-operative day 1 through discharge from hospital
Title
Patient mortality
Time Frame
30 days and 6 months post-operatively
Title
Biomarkers of oxidative stress, IL-6, IL-8 and others
Time Frame
Intraoperatively at cardiopulmonary bypass (CPB)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahzad Shaefi, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21606393
Citation
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Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

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