Clinical Trial

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Recruiting
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Summary
This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.
Trial Details
NCT Number NCT07718295
Lead Sponsor Firat University
Conditions Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine
Enrollment 100 participants
Start Date 2026-06-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-21