Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07344103

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rox ındex

Diagnostic Test

No intervention; observational study only.

Primary outcomes

  1. Early Postoperative Hypoxemia

    Time frame: Within 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.