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Not Yet RecruitingNCT07344103

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

Association of the Preoperative ROX Index With Early Postoperative Hypoxemia in Adult Patients Undergoing Elective Septorhinoplasty and Endoscopic Sinus Surgery: A Prospective Observational Study

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Istinye University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTrox ındexNo intervention; observational study only.

Timeline

Start date
2026-01-15
Primary completion
2026-03-15
Completion
2026-04-01
First posted
2026-01-15
Last updated
2026-01-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07344103. Inclusion in this directory is not an endorsement.

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery (NCT07344103) · Clinical Trials Directory