PreoxygenationPREOXY IINCT07564050
Physiological Effects of Different Preoxygenation Strategies
A study testing Nasal cannula (NC), Non-rebreather mask (NRM) and Non-rebreather mask (NRM) plus Nasal cannula (NC) in people with Preoxygenation, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Nasal cannula (NC), Non-rebreather mask (NRM) and Non-rebreather mask (NRM) plus Nasal cannula (NC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Eurac research, Institute of mountain emergency medicine
Bolzano, BZ, 39100
Giulia Roveri, MD, +390471055115, giulia.roveri@eurac.edu
Simon Rauch, MD, PhD, +390471055544, simon.rauch@eurac.edu
About this study
Official title: Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP
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:
Read more
- 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
Read the detailed description
Hypoxemia is a frequent and potentially life-threatening complication during advanced airway management, associated with adverse outcomes such as hypoxic brain injury, cardiovascular collapse, and death. Effective preoxygenation is essential to increase oxygen reserves and prolong safe apnea time during intubation. Although several devices are routinely used for preoxygenation, including non-rebreather masks (NRM) and bag-valve masks (BVM) with or without positive end-expiratory pressure (PEEP), important uncertainties remain regarding their actual performance and physiological effects.
Current evidence suggests that techniques providing PEEP may improve oxygenation by increasing functional residual capacity, enhancing ventilation of dependent lung regions, and reducing ventilation-perfusion mismatch. However, the relative contribution of FiO₂ delivery versus PEEP, as well as the physiological effects on respiratory mechanics and cardiovascular function, are not fully understood. In addition, it remains unclear whether BVM devices without a dedicated PEEP valve can generate measurable PEEP, and whether patients can generate sufficient inspiratory effort to effectively operate BVM valves without assisted ventilation. Data in pediatric populations are particularly limited.
This randomized crossover study is designed to systematically evaluate the performance of commonly used preoxygenation devices under controlled conditions in healthy adult and pediatric volunteers. By comparing NRM, BVM without PEEP, and BVM with PEEP-with and without supplemental oxygen via nasal cannula-the study aims to characterize differences in oxygen delivery, airway pressure generation, inspiratory effort, and their physiological impact.
The study will focus on key physiological domains, including oxygenation (FiO₂), respiratory mechanics (tidal volume, airway pressures, and diaphragm activity), lung aeration (with particular attention to dependent lung regions), and cardiovascular responses (including right ventricular dimensions and function). Measurements will be obtained using non-invasive monitoring techniques, including gas analysis and ultrasound.
The crossover design allows within-subject comparisons across all study conditions, minimizing inter-individual variability and enabling precise assessment of device-related effects. The findings of this study are expected to improve understanding of the mechanisms and physiological consequences of preoxygenation strategies, with potential implications for optimizing airway management practices in both adult and pediatric populations.
- Conditions
- Preoxygenation
- Being tested
- Nasal cannula (NC), Non-rebreather mask (NRM), Non-rebreather mask (NRM) plus Nasal cannula (NC), Bag-valve mask (BVM) without PEEP, Bag-valve mask (BVM) without PEEP + nasal cannula (NC)
- Keywords
- Preoxygenation, Bag-valve mask (BVM), Non-rebreather mask (NRM), Positive end-expiratory pressure (PEEP), Fraction of inspired oxygen (FiO₂), Respiratory physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 PEEPDevice
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 PEEPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Cannula (NC) | Experimental | Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing. Receives: Device: Nasal cannula (NC) |
| Non-rebreather facemask (NRM) | Experimental | Preoxygenation over 3 minutes with a Non-rebreather facemask (NRM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing. Receives: Device: Non-rebreather mask (NRM) |
| Non-rebreather facemask (NRM) plus Nasal Cannula (NC) | Experimental | Preoxygenation 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. Receives: Device: Non-rebreather mask (NRM) plus Nasal cannula (NC) |
| Bag valve mask (BVM) | Experimental | Preoxygenation for 3 minutes using a bag-valve-mask (BVM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing. Receives: Device: Bag-valve mask (BVM) without PEEP |
| Bag valve mask (BVM) plus Nasal cannula (NC) | Experimental | Preoxygenation 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. Receives: Device: Bag-valve mask (BVM) without PEEP + nasal cannula (NC) |
| Bag valve mask (BVM) plus PEEP | Experimental | Preoxygenation 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. Receives: Device: Bag-valve mask (BVM) with PEEP |
| Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC) | Experimental | Preoxygenation 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. Receives: Device: Bag-valve mask (BVM) with PEEP + nasal cannula (NC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During each 3-minute preoxygenation session
Secondary outcomes (7)
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.
Measured: During each 3-minute preoxygenation session
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.
Measured: During each 3-minute preoxygenation session
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.
Measured: Baseline and at the end of each 3-minute preoxygenation session
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.
Measured: Baseline and at the end of each 3-minute preoxygenation session
Right ventricular strain
Changes in right ventricular strain (%) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.
Measured: Baseline and at the end of each 3-minute preoxygenation session
Ventilation of dependent lung regions
Lung ultrasound will be used to assess regional ventilation of dependent lung areas, with findings quantified using a validated scoring system to compare the effects of preoxygenation with and without PEEP.
Measured: During each 3-minute preoxygenation session
Correlation between FiO₂ and tidal volume
The relationship between fraction of inspired oxygen (FiO₂) and tidal volume during preoxygenation will be assessed using continuous, breath-by-breath measurements.
Measured: During each 3-minute preoxygenation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start23 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Rauch, Institute of Mountain Emergency Medicine
- Investigators
- Simon Rauch, Principal investigator, Eurac research, Institute of mountain emergency medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564050
- Sponsor's protocol ID
- PREOXY II
- Acronym
- PREOXY II
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40392551Rauch S, Pietsch U, Roveri G. Preoxygenation in prehospital critical care: a survey of HEMS practices in eight European countries. Emerg Med J. 2026 Aug 20;43(9):588-589. doi: 10.1136/emermed-2025-215335. No abstract available.
PubMed 41545175
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP
- ClinicalTrials.gov ID
- NCT07564050
- Acronym / sponsor ID
- PREOXY II / PREOXY II
- Conditions
- Preoxygenation
- Keywords
- Preoxygenation, Bag-valve mask (BVM), Non-rebreather mask (NRM), Positive end-expiratory pressure (PEEP), Fraction of inspired oxygen (FiO₂), Respiratory physiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- 23 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Hypoxemia is a frequent and potentially life-threatening complication during advanced airway management, associated with adverse outcomes such as hypoxic brain injury, cardiovascular collapse, and death. Effective preoxygenation is essential to increase oxygen reserves and prolong safe apnea time during intubation. Although several devices are routinely used for preoxygenation, including non-rebreather masks (NRM) and bag-valve masks (BVM) with or without positive end-expiratory pressure (PEEP), important uncertainties remain regarding their actual performance and physiological effects.
Current evidence suggests that techniques providing PEEP may improve oxygenation by increasing functional residual capacity, enhancing ventilation of dependent lung regions, and reducing ventilation-perfusion mismatch. However, the relative contribution of FiO₂ delivery versus PEEP, as well as the physiological effects on respiratory mechanics and cardiovascular function, are not fully understood. In addition, it remains unclear whether BVM devices without a dedicated PEEP valve can generate measurable PEEP, and whether patients can generate sufficient inspiratory effort to effectively operate BVM valves without assisted ventilation. Data in pediatric populations are particularly limited.
This randomized crossover study is designed to systematically evaluate the performance of commonly used preoxygenation devices under controlled conditions in healthy adult and pediatric volunteers. By comparing NRM, BVM without PEEP, and BVM with PEEP-with and without supplemental oxygen via nasal cannula-the study aims to characterize differences in oxygen delivery, airway pressure generation, inspiratory effort, and their physiological impact.
The study will focus on key physiological domains, including oxygenation (FiO₂), respiratory mechanics (tidal volume, airway pressures, and diaphragm activity), lung aeration (with particular attention to dependent lung regions), and cardiovascular responses (including right ventricular dimensions and function). Measurements will be obtained using non-invasive monitoring techniques, including gas analysis and ultrasound.
The crossover design allows within-subject comparisons across all study conditions, minimizing inter-individual variability and enabling precise assessment of device-related effects. The findings of this study are expected to improve understanding of the mechanisms and physiological consequences of preoxygenation strategies, with potential implications for optimizing airway management practices in both adult and pediatric populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Nasal Cannula (NC) | Experimental | Device: Nasal cannula (NC)Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing. |
| Non-rebreather facemask (NRM) | Experimental | Device: Non-rebreather mask (NRM)Preoxygenation 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) | Experimental | Device: Non-rebreather mask (NRM) plus Nasal cannula (NC)Preoxygenation 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) | Experimental | Device: Bag-valve mask (BVM) without PEEPPreoxygenation 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) | Experimental | Device: Bag-valve mask (BVM) without PEEP + nasal cannula (NC)Preoxygenation 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 | Experimental | Device: Bag-valve mask (BVM) with PEEPPreoxygenation 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) | Experimental | Device: Bag-valve mask (BVM) with PEEP + nasal cannula (NC)Preoxygenation 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. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Nasal Cannula (NC) |
| 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 facemask (NRM) |
| 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 | Non-rebreather facemask (NRM) plus Nasal Cannula (NC) |
| Bag-valve mask (BVM) without PEEPPreoxygenation 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) |
| 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) plus Nasal cannula (NC) |
| Bag-valve mask (BVM) with PEEPPreoxygenation 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) plus PEEP |
| 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. | Device | Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC) |
Primary outcome
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices
Time frame: During each 3-minute preoxygenation session
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.
7 secondary outcomes
Positive end-expiratory pressure (PEEP) generated during preoxygenation
Time frame: During each 3-minute preoxygenation session
Inspiratory effort required to open the BVM valve
Time frame: During each 3-minute preoxygenation session
Cardiac output
Time frame: Baseline and at the end of each 3-minute preoxygenation session
Changes in right ventricular dimensions
Time frame: Baseline and at the end of each 3-minute preoxygenation session
Right ventricular strain
Time frame: Baseline and at the end of each 3-minute preoxygenation session
Ventilation of dependent lung regions
Time frame: During each 3-minute preoxygenation session
Correlation between FiO₂ and tidal volume
Time frame: During each 3-minute preoxygenation session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 40392551Roveri 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.
- Background: PubMed 41545175Rauch S, Pietsch U, Roveri G. Preoxygenation in prehospital critical care: a survey of HEMS practices in eight European countries. Emerg Med J. 2026 Aug 20;43(9):588-589. doi: 10.1136/emermed-2025-215335. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Rauch principal investigator
Eurac research, Institute of mountain emergency medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal cannula (NC), Non-rebreather mask (NRM) and Non-rebreather mask (NRM) plus Nasal cannula (NC) in people with Preoxygenation, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Roveri, MD (+390471055115, giulia.roveri@eurac.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices (time frame: During each 3-minute preoxygenation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.