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OpenTrials
Completed

NCT Number: NCT06649279

Oxygen Reserve Index in Different Fresh Gas Flow

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.

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Key information

Conditions

Oxygen Reserve Index Hyperoxia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen reserve index

Device

Measuring oxygen reserve index during preoxygenation and under general anesthesia

Primary outcomes

  1. 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%.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Variations in Oxygen Reserve Index in Different Fresh Gas Flow Rate

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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