Physiological Effects of Different Preoxygenation Strategies

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

Conditions

• Preoxygenation

Interventions

DEVICE

Nasal cannula (NC)

Preoxygenation performed using a nasal cannula delivering supplemental oxygen at a flow rate of 15 L/min, without the use of an additional mask or ventilation device, during spontaneous breathing.

DEVICE

Non-rebreather mask (NRM)

Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L/min. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.

DEVICE

Non-rebreather mask (NRM) plus Nasal cannula (NC)

Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.

DEVICE

Bag-valve mask (BVM) without PEEP

Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.

DEVICE

Bag-valve mask (BVM) without PEEP + nasal cannula (NC)

Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.

DEVICE

Bag-valve mask (BVM) with PEEP

Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.

DEVICE

Bag-valve mask (BVM) with PEEP + nasal cannula (NC)

Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine

  lead OTHER

Principal Investigators

• Simon Rauch · Eurac research, Institute of mountain emergency medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-23

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Italy

Study Locations