Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

NCT04144205 | Completed

• 1 other identifier: PaO2 and SvO2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cerebral regional oxygen saturation

  From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.

Study Arms (1)

Fraction of inspired oxygen setting change

EXPERIMENTAL

Other: Change of the fraction of inspired oxygen

Interventions

Change of the fraction of inspired oxygen OTHER

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).

Fraction of inspired oxygen setting change

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: November 4, 2019
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

KR (1)