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CompletedNCT06649279Updated Oct 18, 2024

Oxygen Reserve Index in Different Fresh Gas Flow

An observational study in Oxygen Reserve Index, sponsored by Sakarya University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Sakarya University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Oxygen Reserve Index

Keywords

  • Oxygen reserve index
  • Minimal flow anesthesia
  • High flow anesthesia
  • Hypoxia
  • Hyperoxia
03

In context

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing elective ear, nose, throat surgery.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Group H

    High Flow Anesthesia Group

    Device: Oxygen reserve index

  • Group M

    Minimal Flow Anesthesia Group

    Device: Oxygen reserve index

Interventions

  • DeviceOxygen reserve index

    Measuring oxygen reserve index during preoxygenation and under general anesthesia

06

What researchers measure

Primary outcomes

  1. Oxygen Reserve Index Value

    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%.

    Time frame: For each patient, from preoxygenation stage to the end of the general anesthesia

07

Study locations

1 site
  • Sakarya University Training and Research Hospital
    Sakarya, 54290, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06649279
Lead sponsor
Sakarya University
Responsible party
Burak Kaya (Medical Doctor, Specialist, Sakarya University) — Principal investigator
First posted
Oct 18, 2024
Start date
Jan 1, 2024
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024
Last update
Oct 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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