Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07564050 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Physiological Effects of Different Preoxygenation Strategies

Study acronym: PREOXY II
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: 5 to 7v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07564050
Lead Sponsor Institute of Mountain Emergency Medicine
Conditions
(from sponsor)		 Preoxygenation
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov