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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144205
Enrollment
40
Registered
2019-10-30
Start date
2019-11-04
Completion date
2020-02-11
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

OTHERChange 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).

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mixed venous oxygen saturationFrom 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

MeasureTime frameDescription
Cerebral regional oxygen saturationFrom 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026