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
|Condition or disease||Intervention/treatment||Phase|
|Hyperoxia Normoxic Delirium||Other: Normoxic oxygenation Other: Hyperoxic oxygenation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- Days of mechanical ventilation [ Time Frame: 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) ]
- Time to extubation [ Time Frame: Post-operative day 1 through discharge from hospital ]
- Patient mortality [ Time Frame: 30 days and 6 months post-operatively ]
- Biomarkers of oxidative stress, IL-6, IL-8 and others [ Time Frame: Intraoperatively at cardiopulmonary bypass (CPB) ]
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
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Shahzad Shaefi, MD||Beth Israel Deaconess Medical Center|