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Completed

NCT Number: NCT07097662

Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

In obese patients, the risk of perioperative complications such as rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia is higher compared to the normal population. Therefore, preoxygenation is even more critical in the obese patient group. In clinical practice, ETO2 is used as a practical indicator to evaluate sufficient oxygenation during preoxygenation. The Oxygen Reserve Index (ORiⓇ) is a new oxygenation monitoring parameter that is continuously and non-invasively measured by a specialized pulse oximetry device (Masimo, Irvine, CA).The primary objective of the investigators was to observe the correlation between ORIⓇ monitoring and ETO₂ during preoxygenation in obese patients.The secondary objective of the investigators was to evaluate the correlation of ORIⓇ with SpO₂ and PaO₂ in this patient population.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

Obesity is a chronic, progressive, and recurrent disease characterized by abnormal fat accumulation that adversely affects health and increases morbidity and mortality.

According to World Health Organization (WHO) data, the prevalence of obesity among adults aged 18 years and older is reported to be 16%.

Obese patients have an increased risk of perioperative complications compared to the general population, including rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia.

Therefore, preoxygenation is particularly important in obese patient populations.

The goal of preoxygenation is to maximize the duration during which the patient can tolerate apnea, thereby providing the anesthesiologist with crucial time to secure the airway in cases of planned or unanticipated "cannot ventilate, cannot intubate" scenarios.

In clinical practice, end-tidal oxygen concentration (ETO₂) is frequently used as a practical indicator to evaluate the adequacy of preoxygenation.

However, achieving a tight-fitting face mask and obtaining accurate ETO₂ measurements can sometimes be challenging.

Thus, alternative monitoring parameters may be needed to evaluate the effectiveness of preoxygenation.

The Oxygen Reserve Index (ORIⓇ) is a novel, continuous, and non-invasive oxygenation monitoring parameter provided by a specialized pulse oximeter (Masimo, Irvine, CA).

While SpO₂ is useful in assessing hypoxia and normoxia, and PaO₂ can evaluate a wide range of oxygenation states, arterial blood gas (ABG) analysis is limited due to its intermittent and invasive nature.

ORIⓇ offers real-time visibility into moderate hyperoxic states (PaO₂ between 100-200 mmHg), which SpO₂ cannot detect.

Several studies have investigated the use of ORIⓇ monitoring to evaluate preoxygenation efficacy in various patient populations.

It has been reported in the literature that ORIⓇ may serve as an early warning indicator of hypoxia and help predict unwanted hyperoxic episodes.

The primary objective of the investigators was to observe the correlation between ORIⓇ monitoring and ETO₂ during preoxygenation in obese patients.The secondary objective of the investigators was to evaluate the correlation of ORIⓇ with SpO₂ and PaO₂ in this patient population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a body mass index (BMI) >35 kg/m² scheduled for elective surgery
  • ASA (American Society of Anesthesiologists) physical status classification I-III
  • Patients aged 18 years and older

Exclusion criteria

  • Patients with ASA physical status classification IV-V,
  • Psychiatric disorders
  • Severe cardiac arrhythmias
  • Patients with an ejection fraction below 30%
  • Chronic obstructive pulmonary disease (COPD)
  • Those receiving home oxygen therapy
  • Patients requiring supraglottic airway devices, and emergency cases

Treatment and study plan

Primary outcomes

  1. Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

    Time frame: During 5-minute preoxygenation

    Non-invasive ORiⓇ values and ETO₂ levels measured every minute during tidal volume breathing in the preoxygenation period will be analyzed for correlation.

Secondary outcomes

  1. Correlation between ORiⓇ and arterial oxygen pressure (PaO₂) at multiple time points after intubation

    Time frame: 30, 60, 90, and 120 minutes after intubation

    ORiⓇ values will be compared with simultaneously obtained arterial blood gas measurements (PaO₂) at predefined time points to assess correlation.

  2. Correlation between ORiⓇ and peripheral oxygen saturation (SpO₂) at multiple time points after intubation

    Time frame: 30, 60, 90, and 120 minutes after intubation

    ORiⓇ values will be compared with corresponding SpO₂ measurements from pulse oximetry to evaluate correlation.

Sponsors and collaborators

Lead sponsor

Irem Caner

Other

Registry information

Acronym: ORi

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 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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