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The Airway Pressures During Bag-Valve-Mask Ventilation

2026年5月13日 更新者:Erkan Göksu、Akdeniz University Hospital

The Airway Pressures During Bag-Valve-Mask Ventilation: A Randomized Crossover Trial

Background and Objective Bag-valve-mask (BVM) ventilation is commonly used in emergency airway management, but the positive pressure generated may increase aspiration risk. This prospective, randomized, simulation-based manikin study aimed to assess how airway pressures change during BVM ventilation using different techniques and neck mobility scenarios.

Methods The study was conducted in a tertiary university hospital between July 15 and August 15, 2024. Emergency medicine residents (PGY-1 to PGY-4) performed ten ventilations using one-hand, two-hand CE, and modified two-hand TE techniques on a manikin under normal and restricted neck mobility. Airway pressures were measured with a real-time pressure sensor. The primary outcome was peak airway pressure; the secondary was the number of ventilations exceeding 20 cmH₂O. All data were automatically recorded, and analyses were performed using SPSS 16.0 with p < 0.05 considered significant.

研究概览

详细说明

Introduction:

Emergency department (ED) patients are considered to have an elevated risk of gastric distention and aspiration of gastric contents, making rapid sequence induction (RSI) the preferred intubation procedure. Pre-oxygenation is likely the most critical step in RSI, as it extends the duration of safe apnea time, providing the operator with more time for the intubation process. Although a facemask with a high FiO2 oxygen reservoir is recommended for pre-oxygenation, bag-valve-mask (BVM) ventilation is frequently used in emergency airway management.

Since its development during the polio epidemic in 1953, the BVM has been used for oxygenation and ventilation of critically ill patients. However, the positive pressure generated by the BVM can increase the risk of regurgitation and aspiration of gastric contents into the lungs. Excessive volumes and flow generated with the BVM can not only lead to gastric distention but also increase intrathoracic pressures, potentially causing negative cardiovascular effects.

The aim of this randomized crossover manikin study is to investigate how airway pressures change during ventilation with a BVM using different scenarios and techniques.

Methods:

This is a randomized crossover trial performed in the simulation lab of a tertiary care facility between 15.07.2024 to 15.08.2024. The ethical committee of XXX approved the study and informed consent was obtained from the participants. The participants were emergency medicine residents ranging from postgraduate year 1 (PGY) to PGY4.

In this study, airway pressures during BVM ventilation were continuously recorded using a calibrated pressure sensor placed between the facemask and the bag. All participants were requested to ventilate the Resusci Anne QCPR airway mannequin (Laerdal Medical, Stavanger, Norway) in a randomized manner using one-hand, two-hand (CE method), and modified two-hand (TE method) techniques, while the airway pressures were measured. Two different scenarios were applied to simulate normal and difficult airways while ventilating the airway mannequin. For the difficult airway scenario, a cervical collar was applied to the airway mannequin. To reduce potential bias, the purpose of the study was not explained to the participants Each participant was asked to provide a sufficient amount of air with the BVM to raise the mannequin's chest and to repeat these 10 times in a randomized order. All the pressure values measured during ventilation were recorded as cmH2O. The highest-pressure value measured during ventilations, as well as the number of ventilations during which the pressure exceeded 20 cmH2O, were recorded.

The differences in the pressure values measured using different hand techniques in normal and difficult airway scenarios were evaluated. Additionally, it was assessed which scenario and technique resulted in pressures exceeding 20 cmH2O, based on the theoretical assumption that pressures above this value would open the lower esophageal sphincter and inflate the stomach with air. This assumption was based on previous studies indicating that lower esophageal sphincter pressure is typically exceeded, and gastric inflation begins, when airway pressure surpasses 20 cmH₂O.

Statistical analysis:

The study data were analyzed using the SPSS software version 16.0 for Windows (SPSS Inc., Chicago, IL, USA). Demographic and baseline characteristics were summarized as a mean ± standard deviation for continuous variables and as a percentage of the group for categorical variables. Non-normally distributed data are presented as medians (interquartile range). For each scenario and technique, the participant was considered the unit of analysis. For every participant, the highest pressure value among the 10 ventilations and whether ≥5 of 10 ventilations exceeded 20 cmH2O were used in the analyses The chi-square test was used to compare the ventilations exceeding the 20 cmH2O pressure value with PGY levels. P < 0.05 was accepted as statistically significant.

研究类型

介入性

注册 (实际的)

46

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 18 years or older.
  • Medical residents (Post-graduate years 1-4) or practicing emergency medicine physicians.
  • Ability and willingness to provide informed consent to participate in the simulation.
  • Experience with basic airway management and BVM ventilation in a clinical setting.

Exclusion Criteria:

  • Lack of Experience:
  • Any musculoskeletal or neurological condition that would prevent the participant from performing manual BVM maneuvers effectively.
  • Refusal to Participate: Inability to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
其他:PGY juniors (under 2 yrs)
Residents who have been working as assistants for less than two years
Describes the CE hand-holding position during the balloon mask ventilation.
Describes the TE hand-holding position during the balloon mask ventilation.
Describes the One hand-holding position during the balloon mask ventilation.
其他:PGY Senior ( above 2 years)
Residents who have been working as assistants for more than two years.
Describes the CE hand-holding position during the balloon mask ventilation.
Describes the TE hand-holding position during the balloon mask ventilation.
Describes the One hand-holding position during the balloon mask ventilation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of airway pressure exceeding 20 cmH2O
大体时间:During the ventilation procedure (a continuous 10-breath sequence per technique/scenario
The frequency of breaths delivered with a peak airway pressure greater than 20 cmH2O (the threshold for gastric inflation risk) during Bag-Valve-Mask (BVM) ventilation.
During the ventilation procedure (a continuous 10-breath sequence per technique/scenario

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 1- Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. 2- Lee CP, Yip YY. Understanding your bag-valve-mask resuscitator. BJA Educ. 2023 Jun;23(6):208-211. doi: 10.1016/j.bjae.2023.03.003. 3- Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation, and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315. 4- Bowman FP, Menegazzi JJ, Check BD, Duckett TM. Lower esophageal sphincter pressure during prolonged cardiac arrest and resuscitation. Ann Emerg Med. 1995 Aug;26(2):216-9. doi: 10.1016/s0196-0644(95)70154-0. 5- von Goedecke A, Wagner-Berger HG, Stadlbauer KH, Krismer AC, Jakubaszko J, Bratschke C, Wenzel V, Keller C. Effects of decreasing peak flow rate on stomach inflation during bag-valve-mask ventilation. Resuscitation. 2004 Nov;63(2):131-6. doi: 10.1016/j.resuscitation.2004.04.012.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月15日

初级完成 (实际的)

2024年8月15日

研究完成 (实际的)

2024年8月15日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • AkdenizUH

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Anonymized data can be shared if deemed appropriate when requested.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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