Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

NCT ID: NCT07344103

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Hypoxemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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rox ındex

No intervention; observational study only.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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İlke Dolgun

assoc. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istinye Üniversity

Istanbul, Merkez Mahallesi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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ilke dolgun

Role: CONTACT

+905555485632

References

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Khurshied S, Zahid MA, Babar A, Rafique MH, Khurshid N, Hussain A, Saif M. Effects of Nasal Packing on Patients' Post-operative Vital Signs. Cureus. 2024 Jun 18;16(6):e62616. doi: 10.7759/cureus.62616. eCollection 2024 Jun.

Reference Type BACKGROUND
PMID: 39027799 (View on PubMed)

Xiong N, Nong Y, Yi Y. Meta-analysis of risk factors associated with postoperative hypoxemia in the postanesthesia care unit. Am J Transl Res. 2024 Oct 15;16(10):5787-5796. doi: 10.62347/LCKG5157. eCollection 2024.

Reference Type BACKGROUND
PMID: 39544775 (View on PubMed)

Other Identifiers

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324-2025

Identifier Type: -

Identifier Source: org_study_id

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