Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144205
• Other study ID #: PaO2 and SvO2
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: February 11, 2020

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mixed venous oxygen saturation	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	Cerebral regional oxygen saturation	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.