Comparison of High-Flow Nasal Oxygen and Face Mask Oxygen for Brain Oxygen Levels During Sedation Outside the Operating Room

What this Trial Is About

Researchers are comparing high-flow nasal oxygen HFNO therapy with conventional face mask oxygen during procedural sedation in adult patients undergoing elective diagnostic or interventional procedures outside the operating room. This randomized controlled trial aims to evaluate cerebral oxygen levels using near-infrared spectroscopy NIRS and assess sedation depth with standardized scales, exploring supportive care methods to improve oxygenation during sedation. Participants are randomly assigned to receive either heated humidified HFNO or conventional face mask oxygen at 6 Lmin with approximately 40% oxygen concentration during procedural sedation. The study continuously monitors regional cerebral oxygen saturation, peripheral oxygen saturation, ventilation parameters, arterial blood gases, sedation depth, and hemodynamic variables throughout the procedure lasting up to about 120 minutes. During the study, participants undergo continuous monitoring of brain and peripheral oxygenation, sedation depth assessments using the Patient State Index and MOAAS scale, and evaluation of airway interventions and satisfaction scores from both patients and practitioners immediately after recovery. The primary outcome is the change in regional cerebral oxygen saturation from sedation initiation to procedure completion, with secondary outcomes including various respiratory and cardiovascular measures. The trial spans from sedation start to procedure completion, focusing on real-time physiological monitoring.

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation