Oxygen Reserve Index-Guided Oxygen Titration During Surgery in the Beach Chair Position

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

This study aims to evaluate whether guidance by the Oxygen Reserve Index (ORi) improves inspiratory oxygen fraction (FiO₂) titration compared with conventional pulse oximetry (SpO₂)-guided oxygen administration in adult patients undergoing surgery in the beach chair position.

Oxygen therapy is routinely used during general anesthesia to prevent hypoxemia; however, excessive oxygen administration may result in hyperoxia, which has been associated with adverse cardiovascular and pulmonary effects. Standard pulse oximetry may not adequately detect hyperoxia when oxygen saturation values are high.

In this prospective comparative study, patients will receive oxygen titration guided either by SpO₂ alone or by combined ORi and SpO₂ monitoring. The primary outcome is the incidence of intraoperative hyperoxemia, assessed by arterial blood gas analysis. Secondary outcomes include intraoperative oxygenation parameters and hemodynamic variables.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients aged 18 to 65 years

American Society of Anesthesiologists (ASA) physical status I-III

Scheduled for elective orthopedic surgery in the beach chair position

Body mass index (BMI) <35 kg/m²

Disqualifiers

Age <18 or ≥65 years

Finger deformities preventing the use of Oxygen Reserve Index (ORi) monitoring

Severe anemia (hemoglobin <8 g/dL)

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • ORi-Guided FiO₂ Titration

    Other intervention

    Inspiratory oxygen fraction (FiO₂) will be adjusted throughout surgery using combined Oxygen Reserve Index (ORi) and peripheral oxygen saturation (SpO₂) monitoring. FiO₂ will be titrated to maintain ORi values between 0.2 and 0.5, with reassessment every 2-3 minutes.

  • SpO₂-Guided FiO₂ Titration

    Other intervention

    FiO₂ will be adjusted to maintain SpO₂ at or above 98% throughout surgery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ORi-Guided FiO₂ TitrationExperimental treatment 1 intervention
Group B: SpO₂-Guided Oxygen TitrationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Intraoperative Severe Hyperoxemia

Severe hyperoxemia will be defined as an arterial partial pressure of oxygen (PaO2) ≥200 mmHg, measured by arterial blood gas analysis at predefined intraoperative time points.

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

Mean Peripheral Oxygen Saturation (SpO2) During Surgery

Peripheral oxygen saturation (SpO2) measured continuously during surgery using standard pulse oximetry.

Time frame
Perioperative/Periprocedural
2

Mean Oxygen Reserve Index (ORi) During Surgery

Oxygen Reserve Index (ORi) values recorded intraoperatively to evaluate oxygenation status.

Time frame
Perioperative/Periprocedural
3

Mean Fraction of Inspired Oxygen (FiO₂) During Surgery

Mean fraction of inspired oxygen (FiO₂) expressed as percentage (%), averaged over the surgical period.

Time frame
Perioperative/Periprocedural
4

Mean Cerebral Oxygen Saturation Measured by Near-Infrared Spectroscopy During Surgery

Cerebral regional oxygen saturation values measured intraoperatively using near-infrared spectroscopy.

Time frame
Intraoperative period (from induction of anesthesia to end of surgery)

Other outcomes

Sponsors and contacts

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