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Not yet recruiting NCT07344103

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

Observational Postoperative Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rox ındex.
Who it may be relevant to
Registry conditions: Postoperative Hypoxemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test rox ındex
    No intervention; observational study only.

Primary outcome measures

  • Early Postoperative Hypoxemia [Time frame: Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

Publications

  • 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. PMID 39027799
  • 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. PMID 39544775

Identifiers

NCT: NCT07344103 · 324-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗