The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery
NCT ID: NCT07326293
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
44 participants
OBSERVATIONAL
2025-12-16
2026-02-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients aged 65 years and older will be monitored using standard anesthesia monitoring and Masimo Rainbow SET® Pulse CO-Oximetry during anesthesia induction and tracheal intubation.
Tolerable apnea time will be defined as the duration from the end of ventilation after intubation to a decrease in peripheral oxygen saturation (SpO₂) to 94%.
The primary objective is to assess the association between ORI warning time and tolerable apnea time. Secondary objectives include evaluating the association between ORI values, arterial blood gas parameters at predefined time points, and the Clinical Frailty Scale.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oxygen Reserve Index in Different Fresh Gas Flow
NCT06649279
The Role of Oxygen Reserve Index (ORi) in Apneic Ventilation
NCT07119866
Oxygen Reserve Index in One-Lung Ventilation During Elective Thoracic Operations
NCT05050552
Comparison of the Effects of High, Low and Minimal Flow Anesthesia Managements on ORI and Partial Oxygen Pressure
NCT05329233
Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index
NCT02707796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, tolerable apnea time will be defined as the time until peripheral oxygen saturation (SpO₂), measured by pulse oximetry, decreases to 94%. Although SpO₂ values of 90% and above have been accepted in the literature, the World Health Organization defines normal SpO₂ as 95% and above and considers values of 94% and below as an indication for treatment.
The Oxygen Reserve Index (ORI) ranges from 0 to 1, and the ORI alarm value triggered by the device due to a downward trend will be recorded. ORI is a dimensionless index ranging from 1 (high oxygen reserve) to 0 (no oxygen reserve), which is measured by optically detecting changes in venous oxygen saturation (SvO₂) after arterial oxygen saturation (SpO₂) reaches 100%. ORI is measured using a multi-wavelength pulse co-oximeter placed on a fingertip.
In addition to routine anesthesia monitoring, including electrocardiography, pulse oximetry, and hemodynamic monitoring, patients will also be monitored using Masimo Rainbow SET® Pulse CO-Oximetry. Due to the oncologic nature of the surgeries and the associated risk of bleeding, close hemodynamic monitoring is required; therefore, invasive arterial blood pressure monitoring will be established in all patients before anesthesia induction.
All patients will be preoxygenated with 100% oxygen for 3 minutes. After establishing intravenous access, anesthesia induction will be performed using intravenous propofol at a dose of 2 mg/kg and fentanyl at a dose of 1 µg/kg. Neuromuscular blockade will be achieved with rocuronium at a dose of 0.6 mg/kg.
All patients will be intubated by an experienced anesthesiologist using a videolaryngoscope. Oxygen Reserve Index (ORI) and peripheral oxygen saturation (SpO₂) values will be recorded, and arterial blood gas analyses will be performed at five predefined time points: baseline (initial values), after 3 minutes of preoxygenation, after 2 minutes of bag-mask ventilation following intubation, during apnea when SpO₂ decreases to 94% without ventilation, and after 2 minutes of ventilation with 100% oxygen.
ORI warning time will be defined as the interval from the onset of the ORI alarm to the decrease of SpO₂ to 94%. SpO₂ warning time will be defined as the duration of the decrease in SpO₂ from 97% to 94%.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
65 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara City Hospital Bilkent
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2-24-8204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.