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NCT Number: NCT07679724

Evaluation of Oxygen Reserve Index (ORi) in Obese and Non-Obese Patients Over 65 Years Old

After obtaining ethical committee approval, this single-center, prospective, observational study included volunteer patients of both sexes, aged 65 years and older, with ASA II-III risk scores, who were scheduled for elective surgery with endotracheal intubation under general anesthesia (GAA). 90 patients were divided into two groups: those with normal BMI (19 < BMI < 25 kg/m² (GROUP 1)) and those who were obese (30 < BMI < 40 kg/m² (GROUP 2)). In addition to standard ASA monitoring, a finger sensor (Rainbow® SET, Masimo Inc., Irvine, Ca., USA) was implanted for ORi measurement, and baseline values were recorded. Patients were preoxygenated until EtO2 (endtidal oxygen) concentration reached at least 85%. After ORi reached a plateau level, general anesthesia was induced and endotracheal intubation was performed. After confirming the tube's position, the breathing circuit was disconnected from the endotracheal tube, and patients were allowed to be apneic until SpO2 reached 94%. Throughout this process, patients' other vital signs, SpO₂, and ORi were continuously monitored. The time elapsed when ORi triggered an alarm, when SpO2 reached 97%, and when SpO2 reached 94% was recorded. The 'ORi warning time', 'SpO2 warning time', and the 'additional warning time provided by ORi' (the difference between 'ORi warning time' and 'SpO2 warning time') were recorded.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients of both sexes aged 65 years and older with ASA II-III risk scores who are scheduled to undergo elective surgical procedures with endotracheal intubation under general anesthesia.

Exclusion criteria

  • Patients under 65 years of age
  • Patients with heart and lung disease
  • Patients in situations where the patient is unable to cooperate (e.g., dementia, Alzheimer's)
  • Patients suspected of having airway difficulties

Treatment and study plan

Primary outcomes

  1. Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two

    Time frame: 15 minutes after preoxygenation

    The primary aim of this study was to determine whether ORi provides an early warning of impending desaturation compared to pulse oximetry in both obese (30 < BMI < 40 kg/m²) and normal body mass index (19 < BMI < 25 kg/m²) patients over 65 years of age scheduled for elective surgery will be assesed until SpO2 drops to 94%

Secondary outcomes

  1. Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two

    Time frame: 15 minutes after preoxygenation

    The secondary objective of this study was to compare the additional stimulus duration provided by ORi in obese (30 < BMI < 40 kg/m²) and normal body mass index (19 < BMI < 25 kg/m²) patients over 65 years of age will be assesed until SpO2 drops to 94%

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of Oxygen Reserve Index (ORi) in Obese and Non-Obese Patients Over 65 Years Old Scheduled for Elective Surgery Under General Anesthesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

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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