Oxygen Reserve Index in Different Fresh Gas Flow

NCT06649279 | Completed FDA Device

• 1 other identifier: E16214662-050.01.04-8172-213
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Reserve Index

Keywords

Oxygen reserve index; Minimal flow anesthesia; High flow anesthesia; Hypoxia; Hyperoxia

Outcome Measures

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%.

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

Study Arms (2)

Group H

High Flow Anesthesia Group

Device: Oxygen reserve index

Group M

Minimal Flow Anesthesia Group

Device: Oxygen reserve index

Interventions

Oxygen reserve index DEVICE

Measuring oxygen reserve index during preoxygenation and under general anesthesia

Group H; Group M

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective ear, nose, throat surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Specialist

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

TU (1)