NCT07344103

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 7, 2026

Last Update Submit

January 15, 2026

Conditions

Postoperative Hypoxemia

Outcome Measures

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.

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

Interventions

rox ındexDIAGNOSTIC_TEST

No intervention; observational study only.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 39027799BACKGROUND

  • 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: 39544775BACKGROUND

Central Study Contacts

ilke dolgun

CONTACT

+905555485632ilkeser2004@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof.

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 15, 2026

Primary Completion

March 15, 2026

Study Completion

April 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

TU(1)