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

Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

Sponsors

Lead sponsor: Seoul National University Hospital

Source Seoul National University Hospital
Brief Summary

Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. However, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. Therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.

Overall Status Completed
Start Date November 4, 2019
Completion Date February 11, 2020
Primary Completion Date February 11, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mixed venous oxygen saturation From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Secondary Outcome
Measure Time Frame
Cerebral regional oxygen saturation From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Enrollment 40
Condition
Intervention

Intervention type: Other

Intervention name: Change of the fraction of inspired oxygen

Description: 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).

Arm group label: Fraction of inspired oxygen setting change

Eligibility

Criteria:

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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Seoul National University Hospital
Location Countries

Korea, Republic of

Verification Date

February 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seoul National University Hospital

Investigator full name: Yunseok Jeon

Investigator title: Professor

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: Fraction of inspired oxygen setting change

Arm group type: Experimental

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov