NCT07326293

Brief Summary

This prospective observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and tolerable apnea time in geriatric patients undergoing elective oncologic surgery under general anesthesia. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 18, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

oxygen reserve indecgeriatricdesaturation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the association between Oxygen Reserve Index (ORI) warning time and tolerable apnea time. ORI warning time is defined as the time interval from the onset of the ORI alarm triggered by a downward trend to the decrease of per

    The primary outcome measure is the association between Oxygen Reserve Index (ORI) warning time and tolerable apnea time. ORI warning time is defined as the time interval from the onset of the ORI alarm triggered by a downward trend to the decrease of peripheral oxygen saturation (SpO₂) to 94%. Tolerable apnea time is defined as the duration from the end of ventilation after tracheal intubation to the decrease of SpO₂ to 94%.

    Peri-induction period at predefined time points baseline; after 3 minutes of preoxygenation; after 2 minutes of bag-mask ventilation following intubation; during apnea at SpO₂ 94%; and after 2 minutes of ventilation with 100% oxygen

Eligibility Criteria

Age65 Years - 100 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

It will be studied in patients over the age of 65.

You may qualify if:

  • Records of patients aged 65 years and older, classified as ASA physical status I-III, who are scheduled for elective oncologic surgery.

You may not qualify if:

  • Records of patients with advanced coronary artery disease; advanced heart failure and/or valvular heart disease; carotid artery stenosis; left ventricular ejection fraction below 30%; rapid atrial fibrillation; body mass index (BMI) greater than 35 kg/m²; anticipated difficult airway; advanced-stage malignancy; or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ApneaHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 8, 2026

Study Start

December 16, 2025

Primary Completion

February 16, 2026

Study Completion

February 16, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations