Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT07303205
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07303205
Study Brief:
Protocol Section:
NCT07303205