Physiological Effects of Different Preoxygenation Strategies

Recruiting now · Not applicable

Conditions studied: Preoxygenation

In brief

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

Key facts

Study ID

NCT07564050

Run by

Institute of Mountain Emergency Medicine

People needed

30

Starts

2026-05-23

Expected to finish

2026-06-30

Last updated by the study team

2026-05-08

Who can join

Age: 5 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Presence of an active airway infection at the time of the study
• Pregnancy
• Refusal or inability to provide informed consent

Where it is running

• Eurac research, Institute of mountain emergency medicine — Bolzano, BZ, Italy (enrolling)

Full record on ClinicalTrials.gov

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