Oxygen Reserve Index and Prevention of Hyperoxemia

May 19, 2023 updated by: Ahmed Uslu, Baskent University Ankara Hospital

Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study

In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.

As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.

There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.

This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

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

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06490
        • Baskent University Ankara Hospital

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

2 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with an American Society of Anesthesiologists (ASA) score of 1

Exclusion Criteria:

  • Patients with an American Society of Anesthesiologists (ASA) score of 2 and above

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group F30
In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.
Drug: Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Device: Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Experimental: Group F50
In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.
Drug: Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Device: Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Experimental: Group F80
In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.
Drug: Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Device: Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FiO2 threshold value
Time Frame: Until the surgery is over
Correlation of FiO2 threshold value and ORi value
Until the surgery is over

Collaborators and Investigators

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

Sponsor

Baskent University Ankara Hospital

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)

August 17, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-05/1838

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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