Clinical Trial

Physiological Effects of Different Preoxygenation Strategies

Study acronym: PREOXY II
Recruiting
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Record status
This record was last updated May 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the performance and physiological effects of different preoxygenation devices in healthy adult and pediatric volunteers (children aged 5-12 years). The study aims to determine how these devices influence oxygen delivery, airway pressure, and cardiopulmonary physiology during preoxygenation. The main questions it aims to answer are: * What fraction of inspired oxygen (FiO₂) is delivered by non-rebreather masks (NRM) compared to bag-valve masks (BVM) with and without positive end-expiratory pressure (PEEP)? * How do these devices differ in terms of generated PEEP, inspiratory effort, and their effects on lung ventilation and cardiac function? Researchers will compare NRM, BVM without PEEP, and BVM with PEEP (each with or without supplemental oxygen via nasal cannula) to evaluate differences in oxygenation and physiological effects. Participants will: * Complete multiple 3-minute preoxygenation sessions using each device in randomized order * Breathe spontaneously through each device, with or without additional oxygen via nasal cannula * Undergo non-invasive monitoring of oxygen concentration (FiO₂), respiratory parameters, airway pressures, and ultrasound assessment of the lungs, diaphragm, and heart * Perform a brief breath-holding maneuver to assess airway pressure generation
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-26.
Trial Details
NCT Number NCT07564050
Lead Sponsor Institute of Mountain Emergency Medicine
Conditions Preoxygenation
Enrollment 30 participants
Start Date 2026-05-23
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08