Oxygen Reserve Index to Reduce Hyperoxia

March 29, 2022 updated by: Eunah Cho, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard group
Fraction of inspired oxygen (FiO2) is titrated guided by SpO2.
Procedure: Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Other Names:
  • SpO2
Experimental: ORI group
Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI
Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Other Names:
  • ORI+SpO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 1 hour of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 2 hours of surgery
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.
After 3 hours of surgery
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.
1 hour after the end of surgery
Fraction of inspired oxygen (FiO2)
Time Frame: 1 hour after the end of surgery
Fraction of inspired oxygen (FiO2) administered during the surgery
1 hour after the end of surgery
Oxygen reserve index (ORI)
Time Frame: 1 hour after the end of surgery
Oxygen reserve idex shown from the monitoring device during the surgery
1 hour after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunah Cho, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-12-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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