- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144205
Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation
Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation and Regional Cerebral Oxygen Saturation During Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.
Exclusion Criteria:
- Emergent surgery
- Symptomatic carotid artery stenosis or carotid artery stenosis of ≥50%
- Preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fraction of inspired oxygen setting change
|
After the stabilization of cardiopulmonary bypass, in the first half of patients, fraction of inspired oxygen would be set at 0.5 and maintained for 5 minutes (T0), then it would be changed to 1.0 and maintained for 5 minutes (T1). Again, fraction of inspired oxygen would be resumed to be 0.5 and maintained for 5 minutes (T2). In the other half of patients, the direction of change in fraction of inspired oxygen will be reversed as follows. It will be set at 1.0 and maintained for 5 minutes (T0), then changed to 0.5 and maintained for 5 minutes (T1), and finally to 1.0 and maintained for 5 minutes (T2). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mixed venous oxygen saturation
Time Frame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
|
Change of mixed venous oxygen saturation according to the fraction of inspired oxygen
|
From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral regional oxygen saturation
Time Frame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
|
Change of cerebral regional oxygen saturation according to the fraction of inspired oxygen
|
From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PaO2 and SvO2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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