Physiological Effects of Different Preoxygenation Strategies (PREOXY II)
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:
- 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Dispositif: Nasal cannula (NC)
- Dispositif: Non-rebreather mask (NRM)
- Dispositif: Non-rebreather mask (NRM) plus Nasal cannula (NC)
- Dispositif: Bag-valve mask (BVM) without PEEP
- Dispositif: Bag-valve mask (BVM) without PEEP + nasal cannula (NC)
- Dispositif: Bag-valve mask (BVM) with PEEP
- Dispositif: Bag-valve mask (BVM) with PEEP + nasal cannula (NC)
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Giulia Roveri, MD
- Numéro de téléphone: +390471055115
- E-mail: giulia.roveri@eurac.edu
Sauvegarde des contacts de l'étude
- Nom: Simon Rauch, MD, PhD
- Numéro de téléphone: +390471055544
- E-mail: simon.rauch@eurac.edu
Lieux d'étude
-
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BZ
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Bolzano, BZ, Italie, 39100
- Recrutement
- Eurac research, Institute of mountain emergency medicine
-
Contact:
- Giulia Roveri, MD
- Numéro de téléphone: +390471055115
- E-mail: giulia.roveri@eurac.edu
-
Contact:
- Simon Rauch, MD, PhD
- Numéro de téléphone: +390471055544
- E-mail: simon.rauch@eurac.edu
-
Sous-enquêteur:
- Ruth Martintoni
-
Chercheur principal:
- Simon Rauch, MD, PhD
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Chercheur principal:
- Giulia Roveri, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Nasal Cannula (NC)
Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
|
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.
|
|
Expérimental: Non-rebreather facemask (NRM)
Preoxygenation over 3 minutes with a Non-rebreather facemask (NRM) with supplemental oxygen delivered at 15 L/min, 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.
|
|
Expérimental: Non-rebreather facemask (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.
|
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.
|
|
Expérimental: Bag valve mask (BVM)
Preoxygenation for 3 minutes using a bag-valve-mask (BVM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
|
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.
|
|
Expérimental: Bag valve mask (BVM) plus 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.
|
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.
|
|
Expérimental: Bag valve mask (BVM) plus PEEP
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.
|
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.
|
|
Expérimental: Bag valve mask (BVM) plus PEEP plus 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices
Délai: 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.
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During each 3-minute preoxygenation session
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Positive end-expiratory pressure (PEEP) generated during preoxygenation
Délai: During each 3-minute preoxygenation session
|
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.
|
During each 3-minute preoxygenation session
|
|
Inspiratory effort required to open the BVM valve
Délai: During each 3-minute preoxygenation session
|
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.
|
During each 3-minute preoxygenation session
|
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Ventilation of dependent lung regions
Délai: During each 3-minute preoxygenation session
|
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.
|
During each 3-minute preoxygenation session
|
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Correlation between FiO₂ and tidal volume
Délai: During each 3-minute preoxygenation session
|
The relationship between fraction of inspired oxygen (FiO₂) and tidal volume during preoxygenation will be assessed using continuous, breath-by-breath measurements.
|
During each 3-minute preoxygenation session
|
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Cardiac output
Délai: Baseline and at the end of each 3-minute preoxygenation session
|
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.
|
Baseline and at the end of each 3-minute preoxygenation session
|
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Changes in right ventricular dimensions
Délai: Baseline and at the end of each 3-minute preoxygenation session
|
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.
|
Baseline and at the end of each 3-minute preoxygenation session
|
|
Right ventricular strain
Délai: Baseline and at the end of each 3-minute preoxygenation session
|
Changes in right ventricular strain (%) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.
|
Baseline and at the end of each 3-minute preoxygenation session
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Airway pressure during breath-holding maneuver
Délai: Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)
|
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.
|
Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Simon Rauch, Eurac research, Institute of mountain emergency medicine
Publications et liens utiles
Publications générales
- 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.
- Rauch 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PREOXY II
Plan pour les données individuelles des participants (IPD)
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