Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04144205

Collaborator

(none)

Enrollment

Location

Arm

3.3

Actual Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Other: Change of the fraction of inspired oxygen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 4, 2019

Actual Primary Completion Date :

Feb 11, 2020

Actual Study Completion Date :

Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fraction of inspired oxygen setting change	Other: Change of the fraction of inspired oxygen 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

Intervention/Treatment

Experimental: Fraction of inspired oxygen setting change

Other: Change of the fraction of inspired oxygen

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).

Outcome Measures

Primary Outcome Measures

Mixed venous oxygen saturation [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

Secondary Outcome Measures

Cerebral regional oxygen saturation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yunseok Jeon, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04144205

Other Study ID Numbers:

PaO2 and SvO2

First Posted:

Oct 30, 2019

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 24, 2020