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NCT Number: NCT07119866

The Role of Oxygen Reserve Index (ORi) in Apneic Ventilation

Background: The Oxygen Reserve Index (ORI) is a non-invasive parameter utilizing multi-wavelength pulse co-oximetry. ORI can provide early warnings of deteriorating oxygenation before changes are reflected in SpO₂ levels. This study aimed to investigate the feasibility of non-ventilated intubation in patients undergoing cholecystectomy as a means to achieve safe intubation without nasogastric tube placement, with reduced trauma and cost, and improved time efficiency.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, çankaya, Turkey (Türkiye)

About this study

Obesity is a complex and chronic disease that significantly impacts respiratory physiology. It leads to increased work of breathing and reduced compliance of the chest wall. In morbidly obese individuals, there is a marked reduction in total lung capacity, vital capacity, forced expiratory volume in one second (FEV1), and forced vital capacity (FVC). Additionally, due to their elevated metabolic demands, these patients exhibit higher oxygen consumption rates.

The Oxygen Reserve Index (ORi) (Masimo Corp., Irvine, CA, USA) is an advanced, continuous, and non-invasive parameter that provides a relative indication of arterial partial pressure of oxygen (PaO₂).

ORI monitoring can be particularly beneficial in patients at risk for inadequate preoxygenation, those with difficult mask ventilation, hypoxemic patients with aspiration risk, rapid sequence induction scenarios, obese individuals, ICU intubations, and invasive ventilation cases. It has also been shown to provide early warnings of desaturation in select patient groups, contributing to improved patient safety.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-60 years
  • ASA 1-2
  • Mallampati score <2
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

  • <18 and >60 years
  • ASA 3-4
  • Initial ORI value below 0.24

Treatment and study plan

OXYGEN RESERVE INDEX

Other

Noted for each patient.

Primary outcomes

  1. TIME FOR ORI TO FALL BELOW 0.24

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    TIME THE PATIENT STARTED TO WEAR A MASKS.

Secondary outcomes

  1. INITIAL ORI VALUE

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  2. ORI VALUE AT 2 MINUTES

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  3. AGE

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  4. American Society of Anesthesiologists (ASA) Score

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  5. SEX

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  6. BMI

    Time frame: WITHIN 10 MINUTES BEFORE INTUBATION

    Noted for each patient.

  7. PRESENCE OF A NASOGASTRIC TUBE

    Time frame: 10 MINUTES BEFORE EXTUBATION

    Noted for each patient.

  8. Surgeon satisfaction

    Time frame: 10 MINUTES BEFORE EXTUBATION

    Noted for each patient. Surgeon satisfaction according to ng usage status.

  9. PRESENCE OF LARYNGOSPASM

    Time frame: 10 MINUTES BEFORE EXTUBATION

    Noted for each patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayça Özcan

CONTACT

[email protected]

05057154125

Ayşegül Özel Erdem

CONTACT

[email protected]

05549777289

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Role of Oxygen Reserve Index (ORi) Monitoring in Optimizing Apneic Ventilation for Laparoscopic Cholecystectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

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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