Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Nasal cannula (NC)

    Device

    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.

  • Non-rebreather mask (NRM)

    Device

    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.

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

    Device

    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.

  • Bag-valve mask (BVM) without PEEP

    Device

    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.

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

    Device

    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.

  • Bag-valve mask (BVM) with PEEP

    Device

    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.

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

    Device

    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.

Treatment groups

30 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Nasal Cannula (NC)Experimental treatment 1 intervention
Group B: Non-rebreather facemask (NRM)Experimental treatment 1 intervention
Group C: Non-rebreather facemask (NRM) plus Nasal Cannula (NC)Experimental treatment 1 intervention
Group D: Bag valve mask (BVM)Experimental treatment 1 intervention
Group E: Bag valve mask (BVM) plus Nasal cannula (NC)Experimental treatment 1 intervention
Group F: Bag valve mask (BVM) plus PEEPExperimental treatment 1 intervention
Group G: Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices

Fraction of inspired oxygen (FiO₂) delivered during preoxygenation will be continuously measured at the airway opening using a gas analyzer. FiO₂ values will be recorded breath-by-breath during each 3-minute preoxygenation session under all study conditions. The primary outcome is the difference in mean FiO₂ achieved between the different preoxygenation devices (non-rebreather mask, bag-valve mask without PEEP, and bag-valve mask with PEEP), with and without supplemental oxygen via nasal cannula.

Time frame
During each 3-minute preoxygenation session

Secondary outcomes

1

Positive end-expiratory pressure (PEEP) generated during preoxygenation

Airway pressures will be continuously measured to quantify the presence and magnitude of PEEP generated during preoxygenation with bag-valve mask (BVM) with and without a dedicated PEEP valve, with and without nasal cannula oxygen supplementation.

Time frame
During each 3-minute preoxygenation session
2

Inspiratory effort required to open the BVM valve

The negative pressure required to open the BVM valve will be measured using airway pressure monitoring, and diaphragm ultrasound parameters (thickening fraction and excursion) will be used as surrogate markers of inspiratory effort.

Time frame
During each 3-minute preoxygenation session
3

Cardiac output

Changes in cardiac output (l/min/m²) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.

Time frame
Baseline and at the end of each 3-minute preoxygenation session
4

Changes in right ventricular dimensions

Changes in right ventricular dimensions (mm) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.

Time frame
Baseline and at the end of each 3-minute preoxygenation session

Other outcomes

1

Airway pressure during breath-holding maneuver

Airway pressure generated during a brief voluntary breath-holding maneuver will be measured when oxygen is delivered via nasal cannula under a bag-valve mask (with or without PEEP), to assess potential continuous positive airway pressure generation.

Time frame
Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Mountain Emergency Medicine

Lead sponsor

Source ClinicalTrials.gov
Apply now