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Physiological Effects of Different Preoxygenation Strategies (PREOXY II)

6 maggio 2026 aggiornato da: Simon Rauch, Institute of Mountain Emergency Medicine

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Italia
    • BZ
      • Bolzano, BZ, Italia, 39100
        • Reclutamento
        • Eurac research, Institute of mountain emergency medicine
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Ruth Martintoni
        • Investigatore principale:
          • Simon Rauch, MD, PhD
        • Investigatore principale:
          • Giulia Roveri, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nasal Cannula (NC)
Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices
Lasso di tempo: 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.
During each 3-minute preoxygenation session

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Positive end-expiratory pressure (PEEP) generated during preoxygenation
Lasso di tempo: 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
Lasso di tempo: 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
Ventilation of dependent lung regions
Lasso di tempo: 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
Correlation between FiO₂ and tidal volume
Lasso di tempo: 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
Cardiac output
Lasso di tempo: 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
Changes in right ventricular dimensions
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Airway pressure during breath-holding maneuver
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institute of Mountain Emergency Medicine

Investigatori

  • Investigatore principale: Simon Rauch, Eurac research, Institute of mountain emergency medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

23 maggio 2026

Completamento primario (Stimato)

30 giugno 2026

Completamento dello studio (Stimato)

30 giugno 2026

Date di iscrizione allo studio

Primo inviato

26 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PREOXY II

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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