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Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

I

Istinye University

Status

Not yet enrolling

Conditions

Postoperative Hypoxemia

Treatments

Diagnostic Test: rox ındex

Study type

Observational

Funder types

Other

Identifiers

NCT07344103
324-2025

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

ilke dolgun

Data sourced from clinicaltrials.gov

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