Actively Recruiting

Phase Not Applicable
Age: 5Years - 75Years
All Genders
Healthy Volunteers
NCT07564050

Physiological Effects of Different Preoxygenation Strategies

Led by Institute of Mountain Emergency Medicine · Updated on 2026-05-08

30

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Physiological Effects of Different Preoxygenation Strategies

Who Can Participate

Age: 5Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with an American Society of Anesthesiologists (ASA) physical status score 64 2
  • Children aged 5 to 12 years with an ASA physical status score 64 2
  • Ability (or legal guardian ability) to provide written informed consent
Not Eligible

You will not qualify if you...

  • Children younger than 5 years or aged 13 to 18 years
  • ASA physical status score greater than 2
  • Body mass index (BMI) 30 kg/m8 or higher
  • Known airway pathology or anatomical abnormality affecting mask fit, ventilation, or oxygenation
  • Active airway infection at the time of the study
  • Pregnancy
  • Refusal or inability to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Eurac research, Institute of mountain emergency medicine

Bolzano, BZ, Italy, 39100

Actively Recruiting

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Research Team

G

Giulia Roveri, MD

CONTACT

S

Simon Rauch, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

7

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