ORI-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by… (NCT07375173) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ORI-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound
74 participantsStarted 2026-03-15
Plain-language summary
Atelectasis is a frequent pulmonary complication after general anesthesia, often triggered by preoxygenation and intraoperative hyperoxia. High inspiratory oxygen fractions (FiO₂) can promote absorption atelectasis, ventilation-perfusion mismatch, hemodynamic alterations, and oxidative injury.
This study evaluates the effect of two intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. Atelectasis severity will be assessed using lung ultrasonography (LUS), scored across 12 thoracic regions (0-3 per region, total 0-36), while respiratory function changes will be examined via preoperative and 24-hour postoperative spirometry (FVC, FEV₁, FEV₁/FVC).
Because postoperative spirometry may be influenced by pain, Numeric Rating Scale (NRS) scores will be recorded to help distinguish true restrictive patterns from pain-limited respiratory effort.
The study aims to determine whether ORI-guided FiO₂ titration can reduce postoperative atelectasis and improve respiratory outcomes compared with a fixed FiO₂ approach.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Adults aged 18 to 80 years
✓. Patients with an ASA physical status of I, II, or III
✓. Individuals with a body mass index (BMI) between 18 and 35 kg/m²
Exclusion criteria
✕. History of or active upper or lower respiratory tract infection within the past month
✕. Pulmonary emphysematous/bullous disease or COPD
✕. Pre-existing significant atelectasis or consolidation (Preoperative LUS showing a score of 3 consolidation or ≥2 regions with a score ≥2)
✕. Severe obstructive sleep apnea requiring CPAP therapy
✕. NYHA class III-IV heart failure, EF \<35%, or severe valvular disease
✕. Severe arrhythmia or hemodynamic instability requiring high-dose vasopressors
✕. Body mass index (BMI) \>35 kg/m²
What they're measuring
1
Change in Total Lung Ultrasound (LUS) Score
Timeframe: Baseline (Preoperative) and 30 Minutes After Extubation