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Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02591589
Recruitment Status : Active, not recruiting
First Posted : October 29, 2015
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shahzad Shaefi, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Hyperoxia Normoxic Delirium Other: Normoxic oxygenation Other: Hyperoxic oxygenation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
Study Start Date : July 2015
Actual Primary Completion Date : January 17, 2018
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Days of mechanical ventilation [ Time Frame: Post-operative day 1 through discharge from hospital (3-5 days on average) ]
  3. Length of stay in hospital [ Time Frame: Post-operative day 1 through discharge from hospital (3-5 days on average) ]
  4. Time to extubation [ Time Frame: Post-operative day 1 through discharge from hospital ]
  5. Patient mortality [ Time Frame: 30 days and 6 months post-operatively ]
  6. Biomarkers of oxidative stress, IL-6, IL-8 and others [ Time Frame: Intraoperatively at cardiopulmonary bypass (CPB) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591589


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Shahzad Shaefi, MD Beth Israel Deaconess Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shahzad Shaefi, Anesthesiologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02591589    
Other Study ID Numbers: 2014P000398
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shahzad Shaefi, Beth Israel Deaconess Medical Center:
Hyperoxia
Delirium
Normoxic
t-MoCA
Additional relevant MeSH terms:
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Delirium
Hyperoxia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Signs and Symptoms, Respiratory