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

The Utility of Oxygen Reserve Index Guidance in Inspiratory Oxygen Titration for Patients Undergoing Surgery in the Beach Chair Position: A Prospective Comparative Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07404267
Acronym
ORI-BCP
Enrollment
80
Registered
2026-02-11
Start date
2026-02-15
Completion date
2026-07-31
Last updated
2026-02-11

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

Conditions

Beach Chair Position, Cerebral Oxygenation, Hyperoxemia, Intraoperative Oxygen Therapy

Keywords

Oxygen Reserve Index, ORİ, FiO2 titration, Hyperoxia, Pulse oximetry, Arterial blood gas, Near-infrared spectroscopy, General anesthesia, Beach chair position, Orthopedic surgery

Brief summary

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.

Detailed description

This prospective study will be conducted in adult patients (ASA physical status I-III) undergoing elective orthopedic surgery in the beach chair position under general anesthesia. Following approval by the institutional ethics committee and acquisition of written informed consent, eligible patients will be included in the study. Standard monitoring will include electrocardiography, noninvasive blood pressure, peripheral oxygen saturation (SpO₂), bispectral index (BIS), perfusion index (PI), pleth variability index (PVI), near-infrared spectroscopy (NIRS), and multiwavelength pulse co-oximetry for Oxygen Reserve Index (ORi) monitoring. Invasive arterial blood pressure monitoring will be established via radial arterial cannulation to allow continuous hemodynamic monitoring and arterial blood gas sampling. General anesthesia will be induced with intravenous propofol, fentanyl, and rocuronium, followed by orotracheal intubation. Mechanical ventilation will be applied in volume-controlled mode with lung-protective settings. Anesthesia will be maintained using sevoflurane and remifentanil infusion, targeting bispectral index values between 40 and 60. From anesthesia induction onward, inspiratory oxygen fraction (FiO₂) will be titrated either according to SpO₂ values alone or using combined ORi and SpO₂ guidance. In the ORi-guided group, FiO₂ adjustments will aim to maintain ORi values between 0.2 and 0.5, with reassessment at regular intervals. In the SpO₂-guided group, FiO₂ will be adjusted to maintain SpO₂ values at or above 98%, in accordance with routine clinical practice. Hemodynamic parameters, oxygenation variables, ORi values, and cerebral oxygenation assessed by NIRS will be recorded at predefined time points during surgery and recovery. Arterial blood gas analysis will be performed to determine PaO₂ and arterial oxygen saturation. Hyperoxemia will be defined as a PaO₂ value of 100 mmHg or greater and classified as mild or severe. The primary outcome of the study is the incidence of intraoperative severe hyperoxemia. Secondary outcomes include overall oxygenation profiles and intraoperative hemodynamic stability. The results of this study are expected to provide evidence regarding the utility of ORi-guided oxygen titration in reducing unnecessary hyperoxia during surgery performed in the beach chair position.

Interventions

OTHERORi-Guided FiO₂ Titration

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.

OTHERSpO₂-Guided FiO₂ Titration

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

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Participants will be assigned to one of two parallel groups in which inspiratory oxygen fraction (FiO₂) is titrated either using combined Oxygen Reserve Index (ORi) and SpO₂ guidance or SpO₂ guidance alone throughout surgery.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 * Ability to provide written informed consent

Exclusion criteria

* Age \<18 or ≥65 years * Finger deformities preventing the use of Oxygen Reserve Index (ORi) monitoring * Severe anemia (hemoglobin \<8 g/dL) * Pregnancy * Refusal or inability to provide informed consent * History of stroke or significant vascular pathology * Severe cardiac or respiratory disease

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Intraoperative Severe HyperoxemiaPerioperative/PeriproceduralSevere 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.

Secondary

MeasureTime frameDescription
Mean Peripheral Oxygen Saturation (SpO2) During SurgeryPerioperative/PeriproceduralPeripheral oxygen saturation (SpO2) measured continuously during surgery using standard pulse oximetry.
Mean Oxygen Reserve Index (ORi) During SurgeryPerioperative/PeriproceduralOxygen Reserve Index (ORi) values recorded intraoperatively to evaluate oxygenation status.
Mean Fraction of Inspired Oxygen (FiO₂) During SurgeryPerioperative/PeriproceduralMean fraction of inspired oxygen (FiO₂) expressed as percentage (%), averaged over the surgical period.
Mean Cerebral Oxygen Saturation Measured by Near-Infrared Spectroscopy During SurgeryIntraoperative period (from induction of anesthesia to end of surgery)Cerebral regional oxygen saturation values measured intraoperatively using near-infrared spectroscopy.

Countries

Turkey (Türkiye)

Contacts

CONTACTcagla sancak, md
caglasancakk@gmail.com+905064381002
PRINCIPAL_INVESTIGATORcagla sancak, MD

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026