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Physiological Effects of Different Preoxygenation Strategies

RecruitingNAAges 5 Years - 75 YearsAllInstitute of Mountain Emergency Medicine
NCT07564050 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Partici

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📋 Eligibility rules (as published)
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
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What it tests

  • 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)
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Where

1 site
Eurac research, Institute of mountain emergency medicine
Bolzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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