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临床试验/NCT07591909
NCT07591909已完成不适用

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

Akdeniz University Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1

研究概览

简要总结

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.

详细描述

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:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Akdeniz University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkan Göksu

MD

Akdeniz University Hospital

研究点 (1)

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