Clinical Trial

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

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Record status
This record was last updated January 20, 2026 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
Early postoperative hypoxemia is a frequent complication after elective ear, nose, and throat (ENT) surgery and may adversely affect recovery in the post-anesthesia care unit (PACU). Simple and non-invasive preoperative tools to identify patients at risk for early postoperative hypoxemia are limited. The ROX index, calculated using oxygen saturation, fraction of inspired oxygen, and respiratory rate, is an easily applicable bedside parameter that has been shown to predict respiratory deterioration in various clinical settings. However, its predictive value in the preoperative period for patients undergoing elective ENT surgery has not been well established. This prospective observational study aims to evaluate the association between the preoperative ROX index measured on room air and early postoperative hypoxemia in adult patients undergoing elective septorhinoplasty or endoscopic sinus surgery under general anesthesia. Early postoperative hypoxemia will be defined as oxygen saturation below 92% or the need for supplemental oxygen at a flow rate of 4 L/min or higher within the first 30 minutes after PACU admission. The predictive performance of the ROX index will be assessed using receiver operating characteristic (ROC) analysis.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-07.
Trial Details
NCT Number NCT07344103
Lead Sponsor Istinye University
Conditions Postoperative Hypoxemia
Enrollment 80 participants
Start Date 2026-01-15
Primary Completion 2026-03-15 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-20