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临床试验/NCT07564050
NCT07564050招募中不适用

Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP

Institute of Mountain Emergency Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Non-rebreather mask (NRM) plus Nasal cannula (NC) (Device)

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.

干预措施: Non-rebreather mask (NRM) (Device)

Nasal Cannula (NC)

Experimental

Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.

干预措施: Nasal cannula (NC) (Device)

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.

干预措施: Bag-valve mask (BVM) without PEEP (Device)

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.

干预措施: Bag-valve mask (BVM) without PEEP + nasal cannula (NC) (Device)

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.

干预措施: Bag-valve mask (BVM) with PEEP (Device)

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.

干预措施: Bag-valve mask (BVM) with PEEP + nasal cannula (NC) (Device)

结局指标

主要结局

Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Rauch

MD, PhD

Institute of Mountain Emergency Medicine

研究点 (1)

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