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NCT Number: NCT07415161

Oxygen Reserve Index (ORi) in Identifying Desaturation

This randomized clinical trial investigates whether Oxygen Reserve Index (ORi) monitoring enables earlier detection of impending hypoxemia compared with conventional pulse oximetry during apneic intermittent ventilation in adult patients undergoing endolaryngeal surgery under general anesthesia. By providing continuous, noninvasive assessment of oxygen reserve in the hyperoxic range, ORi may offer an earlier warning of oxygen depletion before peripheral oxygen saturation declines. The study compares time to reventilation thresholds, arterial blood gas parameters, and perioperative respiratory outcomes between ORi-guided and standard SpO₂-guided monitoring strategies.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Department of anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location contact

demet altun, prof

CONTACT

[email protected]

00905326811767

About this study

This prospective, single-center, randomized clinical trial was designed to evaluate the role of the Oxygen Reserve Index (ORi) in the early detection of hypoxemia during apneic intermittent ventilation in adult patients undergoing elective endolaryngeal surgery under general anesthesia. Endolaryngeal procedures require shared airway management and frequently involve apneic periods, during which conventional pulse oximetry may fail to provide timely warning of declining oxygen reserves due to the plateau phase of the oxyhemoglobin dissociation curve. Eligible patients aged 18 years and older with ASA physical status I-III were randomly assigned to either an ORi-monitored group or a control group monitored with standard peripheral oxygen saturation (SpO₂). All patients underwent standardized anesthesia induction, preoxygenation, and apneic intermittent ventilation. In the ORi group, the threshold for resuming ventilation was defined as ORi reaching zero, whereas in the control group ventilation was resumed when SpO₂ decreased to 90%. The primary outcome was the time from the onset of apnea to the predefined reventilation threshold. Secondary outcomes included arterial blood gas parameters (pH, PaO₂, PaCO₂) at the time of reventilation, end-tidal carbon dioxide levels, perioperative lung ultrasound findings, post-anesthesia care unit length of stay, and postoperative respiratory outcomes. This study aims to determine whether ORi monitoring provides earlier and clinically meaningful warning of oxygen reserve depletion compared with conventional pulse oximetry, potentially improving patient safety during shared-airway surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 years or older
  • Scheduled for elective endolaryngeal surgery
  • Planned general anesthesia with apneic intermittent ventilation
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to provide written informed consent

Exclusion criteria

  • Age under 18 years
  • Preoperative chronic hypoxemia (baseline SpO₂ < 95%)
  • Patients transferred from the intensive care unit
  • ASA physical status IV or higher
  • Refusal or inability to provide informed consent

Treatment and study plan

oxygen monitoring techniques

Procedure

to determine whether ORi monitoring provides earlier and clinically meaningful warning of oxygen reserve depletion compared with conventional pulse oximetry, potentially improving patient safety during shared-airway surgery.

Primary outcomes

  1. Time to Reventilation Threshold

    Time frame: From the onset of apnea until the predefined reventilation threshold is reached during the intraoperative period (within minutes).

    Time from the onset of apnea to the predefined reventilation threshold, defined as Oxygen Reserve Index (ORi) reaching zero in the ORi group and peripheral oxygen saturation (SpO₂) decreasing to 90% in the control group, measured in seconds.

Secondary outcomes

  1. Arterial Blood Gas Parameters at Reventilation

    Time frame: From the onset of apnea until the predefined reventilation threshold is reached during the intraoperative period (within minutes).

    Arterial blood gas values including pH, partial pressure of oxygen (PaO₂), and partial pressure of carbon dioxide (PaCO₂) measured at the time of reventilation.

  2. Perioperative Lung Ultrasound Findings

    Time frame: Preoperatively (before anesthesia induction) and postoperatively in the post-anesthesia care unit (within 1 hour after surgery).

    Change in lung ultrasound (LUS) B-line count between preoperative and postoperative assessments.

  3. Postoperative Oxygenation

    Time frame: postoperatively in the post-anesthesia care unit (within 1 hour after surgery).

    Lowest peripheral oxygen saturation (SpO₂) recorded during PACU stay.

  4. End-Tidal Carbon Dioxide (EtCO₂) Level

    Time frame: During the apneic period, measured at the time of reventilation during surgery.

    First recorded EtCO₂ value during apnea prior to reventilation.

Study contacts

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

Demet Altun, Prof

CONTACT

[email protected]

00905326811767

ece naz demir, resident

CONTACT

[email protected]

00905064524892

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Role of Oxygen Reserve Index (ORi) in Identifying Early Desaturation During Endolaryngeal Surgery: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 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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