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NCT Number: NCT04144205

Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Mixed venous oxygen saturation

    Time frame: 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 outcomes

  1. Cerebral regional oxygen saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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