Physiological Effects of Different Preoxygenation Strategies
PREOXY II
1 other identifier
interventional
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2026
CompletedFirst Posted
Study publicly available on registry
May 4, 2026
CompletedStudy Start
First participant enrolled
May 23, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
Study Completion
Last participant's last visit for all outcomes
June 30, 2026
May 4, 2026
April 1, 2026
1 month
April 26, 2026
April 26, 2026
Conditions
Keywords
Outcome Measures
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.
During each 3-minute preoxygenation session
Secondary Outcomes (5)
Positive end-expiratory pressure (PEEP) generated during preoxygenation
During each 3-minute preoxygenation session
Inspiratory effort required to open the BVM valve
During each 3-minute preoxygenation session
Cardiac function and hemodynamic changes
Baseline and at the end of each 3-minute preoxygenation session
Ventilation of dependent lung regions
During each 3-minute preoxygenation session
Correlation between FiO₂ and tidal volume
During each 3-minute preoxygenation session
Other Outcomes (1)
Airway pressure during breath-holding maneuver
Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)
Study Arms (7)
Nasal Cannula (NC)
EXPERIMENTALPreoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
Non-rebreather facemask (NRM)
EXPERIMENTALPreoxygenation over 3 minutes with a Non-rebreather facemask (NRM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
Non-rebreather facemask (NRM) plus Nasal Cannula (NC)
EXPERIMENTALPreoxygenation for 3 minutes using a non-rebreather mask (NRM) combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
Bag valve mask (BVM)
EXPERIMENTALPreoxygenation for 3 minutes using a bag-valve-mask (BVM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
Bag valve mask (BVM) plus Nasal cannula (NC)
EXPERIMENTALPreoxygenation for 3 minutes using a bag -valve-mask (BVM) combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
Bag valve mask (BVM) plus PEEP
EXPERIMENTALPreoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O and supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC)
EXPERIMENTALPreoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O, combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
Interventions
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eurac research, Institute of mountain emergency medicine
Bolzano, BZ, 39100, Italy
Related Publications (2)
Roveri G, Camporesi A, Hofer A, Kahlen S, Breidt F, Rauch S. Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511569. doi: 10.1001/jamanetworkopen.2025.11569.
PMID: 40392551BACKGROUNDRauch S, Pietsch U, Roveri G. Preoxygenation in prehospital critical care: a survey of HEMS practices in eight European countries. Emerg Med J. 2026 Jan 16:emermed-2025-215335. doi: 10.1136/emermed-2025-215335. Online ahead of print. No abstract available.
PMID: 41545175BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Rauch
Eurac research, Institute of mountain emergency medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 26, 2026
First Posted
May 4, 2026
Study Start (Estimated)
May 23, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share