Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery

December 11, 2025 updated by: İlke Dolgun, Istinye University

Predictive Value of the Preoperative ROX Index for Early Postoperative Hypoxemia in Bariatric Surgery Patients: A Prospective Observational Cohort Study

This prospective observational study evaluates whether the preoperative ROX index can predict early postoperative hypoxemia in patients undergoing bariatric surgery. Preoperative ROX measurements, along with ARISCAT and STOP-Bang scores, will be assessed for their association with hypoxemia occurring within the first 12 postoperative hours.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients scheduled for elective bariatric surgery, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. All participants are obese (BMI ≥ 35 kg/m²) and evaluated preoperatively in the anesthesia clinic prior to surgery.

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • Scheduled for elective bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)
  • Body mass index (BMI) ≥ 35 kg/m²
  • ASA physical status I-III
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Acute respiratory failure, pneumonia, or active pulmonary infection
  • Receiving oxygen therapy or respiratory support (nasal cannula, CPAP, BiPAP, or high-flow oxygen) preoperatively
  • Preoperative SpO₂ < 88% on room air
  • Significant cardiac arrhythmia, severe heart failure (NYHA class III-IV), or hemodynamic instability
  • Pregnancy, active malignancy, or current immunosuppressive therapy
  • Inability to complete postoperative follow-up or early discharge before 12-hour assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Postoperative Hypoxemia
Time Frame: Postoperative 0-12 hours
Hypoxemia defined as SpO₂ < 92% or new oxygen requirement within the first postoperative hours.
Postoperative 0-12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

February 25, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • erkan rox indeksi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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