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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

46

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の: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.
他の: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of airway pressure exceeding 20 cmH2O
時間枠: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

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

  • 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.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年7月15日

一次修了 (実際)

2024年8月15日

研究の完了 (実際)

2024年8月15日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月18日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • AkdenizUH

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Anonymized data can be shared if deemed appropriate when requested.

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