Oxygen Reserve Index in Different Fresh Gas Flow

October 17, 2024 updated by: Burak Kaya, Sakarya University

Variations in Oxygen Reserve Index in Different Fresh Gas Flow Rate

Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

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
      • Sakarya, Turkey, 54290
        • Sakarya University Training and Research 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective ear, nose, throat surgery.

Description

Inclusion Criteria:

  • ASA I-III patients
  • 18-75 years old
  • underwent general anesthesia
  • elective ear, nose and throat surgery, lasting longer than 60 minutes

Exclusion Criteria:

  • who did not consent to participate,
  • those with finger deformities
  • unregulated diabetes mellitus, severe heart, kidney, or liver failure, sensitivities to local anesthetics or opioids, those who were morbidly obese (BMI >40 kg/m²), and breastfeeding women.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group H
High Flow Anesthesia Group
Device: Oxygen reserve index
Measuring oxygen reserve index during preoxygenation and under general anesthesia
Group M
Minimal Flow Anesthesia Group
Device: Oxygen reserve index
Measuring oxygen reserve index during preoxygenation and under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Reserve Index Value
Time Frame: For each patient, from preoxygenation stage to the end of the general anesthesia
The Oxygen Reserve Index (ORI) is a real-time monitoring measure that captures the oxygen reserve status in the moderate hyperoxic range (PaO2 approximately 100 to 200 mmHg). ORI provides early warning of potential oxygenation disturbances before any changes occur in SpO2 and indicates the response to oxygen therapy. ORI ranges from 1 (high reserve) to 0 (no reserve) and measures changes in mixed venous oxygen saturation (SvO2) optically after arterial oxygen saturation reaches 100%.
For each patient, from preoxygenation stage to the end of the general anesthesia

Collaborators and Investigators

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

Sponsor

Sakarya University

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)

January 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E16214662-050.01.04-8172-213

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

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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