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NCT Number: NCT07303205

Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery

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.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

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

  • 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

Treatment and study plan

Preoperative ROX Index Assessment

Other

Participants will undergo a preoperative assessment including measurement of the ROX index (SpO₂/FiO₂ divided by respiratory rate) before bariatric surgery. No treatment or study-related intervention will be applied; all perioperative care will follow routine clinical practice.

Primary outcomes

  1. Early Postoperative Hypoxemia

    Time frame: Postoperative 0-12 hours

    Hypoxemia defined as SpO₂ < 92% or new oxygen requirement within the first postoperative hours.

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Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

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.

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