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Not yet recruiting NCT07303205

Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery

Observational Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative ROX Index Assessment.
Who it may be relevant to
Registry conditions: Hypoxemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Early Postoperative Hypoxemia [Time frame: Postoperative 0-12 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

Publications

  • Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4. PMID 41188672
  • Wang X, Guo K, Sun J, Yang Y, Wu Y, Tang X, Xu Y, Chen Q, Zeng S, Wang L, Liu S. Semirecumbent Positioning During Anesthesia Recovery and Postoperative Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2416797. doi: 10.1001/jamanetworkopen.2024.16797. PMID 38941098
  • Lee S, Hong H, Cho H, Lee SW, You AH, Kang HY, Park SW, Kim MK, Choi JH. Association between preoperative oxygen reserve index and postoperative pulmonary complications: a prospective observational study. Korean J Anesthesiol. 2025 Jun;78(3):224-235. doi: 10.4097/kja.24420. Epub 2025 Feb 17. PMID 40468628

Identifiers

NCT: NCT07303205 · erkan rox indeksi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗