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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07344103
Enrollment
80
Registered
2026-01-15
Start date
2026-01-15
Completion date
2026-04-01
Last updated
2026-01-20

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

Conditions

Postoperative Hypoxemia

Brief 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.

Interventions

DIAGNOSTIC_TESTrox ındex

No intervention; observational study only.

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18 and 65 years * American Society of Anesthesiologists (ASA) physical status I-II * Scheduled for elective septorhinoplasty or endoscopic sinus surgery * Undergoing surgery under general anesthesia * Ability to undergo preoperative measurement of oxygen saturation and respiratory rate on room air * Provision of written informed consent

Exclusion criteria

* Age \<18 years or \>65 years * ASA physical status III or higher * Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, pulmonary hypertension, severe heart failure) * Active respiratory tract infection in the preoperative period * Body mass index (BMI) \>35 kg/m² * Requirement for long-term supplemental oxygen therapy * Refusal or inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Early Postoperative HypoxemiaWithin the first 30 minutes after admission to the post-anesthesia care unit (PACU)Early postoperative hypoxemia will be defined as an oxygen saturation (SpO₂) below 92% or the requirement for supplemental oxygen at a flow rate of 4 L/min or higher.

Countries

Turkey (Türkiye)

Contacts

CONTACTilke dolgun
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026