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Clinical Trials in Turkey / NCT07303205
Starting soon Observational

Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery

NCT07303205 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istinye University
Phase
Observational
Started
2025-12-25
Last updated
2025-12-24

Condition(s) studied

Hypoxemia

Investigational drug(s) / intervention(s)

Preoperative ROX Index Assessment

Preoperative ROX Index Assessment: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Early Postoperative Hypoxemia — Postoperative 0-12 hours
    Hypoxemia defined as SpO₂ \< 92% or new oxygen requirement within the first postoperative hours.

Trial sites (1)

FacilityCityRegionStatus
Istinye Üniversity Istanbul Merkez Mahallesi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303205 on ClinicalTrials.gov ↗ ← All trials in Turkey