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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07119866
Enrollment
60
Registered
2025-08-13
Start date
2025-08-07
Completion date
2025-08-30
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Body Mass Index, Oxygen Reserve Index, Ventilation

Brief summary

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.

Detailed description

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.

Interventions

OTHEROXYGEN RESERVE INDEX

Noted for each patient.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TIME FOR ORI TO FALL BELOW 0.24WITHIN 10 MINUTES BEFORE INTUBATIONTIME THE PATIENT STARTED TO WEAR A MASKS.

Secondary

MeasureTime frameDescription
ORI VALUE AT 2 MINUTESWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.
AGEWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.
American Society of Anesthesiologists (ASA) ScoreWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.
SEXWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.
INITIAL ORI VALUEWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.
PRESENCE OF A NASOGASTRIC TUBE10 MINUTES BEFORE EXTUBATIONNoted for each patient.
Surgeon satisfaction10 MINUTES BEFORE EXTUBATIONNoted for each patient. Surgeon satisfaction according to ng usage status.
PRESENCE OF LARYNGOSPASM10 MINUTES BEFORE EXTUBATIONNoted for each patient.
BMIWITHIN 10 MINUTES BEFORE INTUBATIONNoted for each patient.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyşegül Özel Erdem
aysegulozell@gmail.com05549777289
Backup ContactAyça Özcan
draycaozcan@gmail.com05057154125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026