Physiological Effects of Different Preoxygenation Strategies
ConditionPreoxygenation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-75
SponsorInstitute of Mountain Emergency Medicine
About this trial
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
Eligibility criteria
Qualifiers
Adults with an American Society of Anesthesiologists (ASA) physical status score ≤ 2
Children aged 5 to 12 years with an ASA physical status score ≤ 2
Ability (or legal guardian ability) to provide written informed consent
Disqualifiers
Children aged < 5 years or 13 to 18 years
ASA physical status score > 2
Body mass index (BMI) ≥ 30 kg/m²
Known airway pathology or anatomical abnormality that could affect mask fit, ventilation, or oxygenation
Trial design
Treatments tested in this trial
- Nasal cannula (NC)
- Non-rebreather mask (NRM)
- Non-rebreather mask (NRM) plus Nasal cannula (NC)
- Bag-valve mask (BVM) without PEEP
- Bag-valve mask (BVM) without PEEP + nasal cannula (NC)
- Bag-valve mask (BVM) with PEEP
- Bag-valve mask (BVM) with PEEP + nasal cannula (NC)
Treatment groups
30 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov