ORI-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound

NCT07375173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • Atelectases, Postoperative Pulmonary
  • Prone Position
  • Spine Surgery
  • Lung Ultrasound
  • Oxygen Reserve Index

Interventions

PROCEDURE

Titrated Oxygen

This intervention is distinguished by the use of real-time Oxygen Reserve Index (ORI) monitoring to guide individualized intraoperative FiO₂ titration. Unlike fixed-FiO₂ strategies commonly used in anesthesia practice, this protocol continuously adjusts FiO₂ based on ORI values measured with the Masimo Rad-97 device. FiO₂ is increased or decreased in increments of 0.05 according to predefined ORI thresholds to maintain patients within a targeted normoxemic range. The intervention is entirely noninvasive and integrates standardized lung ultrasound (LUS) assessments and spirometry to evaluate postoperative aeration loss and respiratory function. This dynamic, physiology-based oxygen management approach differentiates the intervention from routine fixed-oxygen administration used in other clinical studies.

PROCEDURE

Fixed oxygen

This intervention uses a standard, non-individualized oxygen administration approach in which FiO₂ is maintained at a constant 50% throughout the entire surgical procedure. After preoxygenation with 80% FiO₂ for 3 minutes, the FiO₂ is set at 0.50 immediately after intubation and is not modified in response to patient physiology or ORI measurements. PEEP is fixed at 5 cmH₂O, and a standardized alveolar recruitment maneuver is applied at the beginning of surgery. This fixed-FiO₂ strategy differs from the ORI-guided titration group by avoiding dynamic oxygen adjustments and reflects conventional intraoperative oxygen management commonly used in clinical practice.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Principal Investigators

  • Derya Özkan, Professor · Ankara Etlik City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-09-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07375173 on ClinicalTrials.gov