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Completed

NCT Number: NCT04211246

Oxygen Reserve Index to Reduce Hyperoxia

Excessive oxygen administration is known to cause oxidative stress, and absorption atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are concerns in using excessive oxygen during general anesthesia, the optimal fraction of inspired oxygen (FiO2) for general anesthesia is not well studied.

The oxygen reserve index (ORI) is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORI that it might be helpful to reduce hyperoxia in critically ill patients in the intensive care unit, as well as in general anesthesia.

The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia in major abdominal surgery.

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Key information

Conditions

Hyperoxemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
  • Patients who are scheduled for invasive arterial cannulation during surgery.

Exclusion criteria

  • Abnormal pulmonary function test
  • Pregnancy
  • Saturation of oxygen (SpO2) is below 92% in room air

Treatment and study plan

Titration of fraction of inspired oxygen (FiO2) guided by SpO2

Procedure

Titration of fraction of inspired oxygen (FiO2) guided by SpO2

Other names: SpO2

Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2

Procedure

Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2

Other names: ORI+SpO2

Primary outcomes

  1. Pressure of arterial oxygen (PaO2) after 1 hour of surgery.

    Time frame: After 1 hour of surgery

    Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

Secondary outcomes

  1. Pressure of arterial oxygen (PaO2) after 2 hours of surgery.

    Time frame: After 2 hours of surgery

    Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

  2. Pressure of arterial oxygen (PaO2) after 3 hours of surgery.

    Time frame: After 3 hours of surgery

    Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

  3. Minimal and maximal value of PaO2 throughout the surgery

    Time frame: 1 hour after the end of surgery

    Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

  4. Fraction of inspired oxygen (FiO2)

    Time frame: 1 hour after the end of surgery

    Fraction of inspired oxygen (FiO2) administered during the surgery

  5. Oxygen reserve index (ORI)

    Time frame: 1 hour after the end of surgery

    Oxygen reserve idex shown from the monitoring device during the surgery

Sponsors and collaborators

Lead sponsor

Eunah Cho, MD

Other

Registry information

Official study title

Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Mar 31, 2022

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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