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Not yet recruitingNCT07344103Updated Jan 20, 2026

Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery

An observational study in Postoperative Hypoxemia, sponsored by Istinye University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Istinye University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Postoperative Hypoxemia
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In context

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective septorhinoplasty or endoscopic sinus surgery under general anesthesia will be included in this study. All participants will undergo standard preoperative assessment, including measurement of oxygen saturation and respiratory rate on room air, and will be monitored postoperatively in the post-anesthesia care unit (PACU) according to routine clinical practice.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testrox ındex

    No intervention; observational study only.

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What researchers measure

Primary outcomes

  1. Early Postoperative Hypoxemia

    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.

    Time frame: Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)

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Study locations

1 site
  • Istinye Üniversity
    Istanbul, Merkez Mahallesi 34250, Turkey (Türkiye)
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References and documents

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. PubMed 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. PubMed 39544775 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07344103
Lead sponsor
Istinye University
Responsible party
İlke Dolgun (assoc. prof., Istinye University) — Principal investigator
First posted
Jan 15, 2026
Start date
Jan 15, 2026 (estimated)
Primary completion
Mar 15, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

ilke dolgun
Contact
ilkeser2004@gmail.com
+905555485632

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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