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临床试验/NCT04988906
NCT04988906已完成不适用

Monitoring Ventilations During Out-of-Hospital Cardiac Arrest Resuscitation

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2021年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
412
试验地点
2
主要终点
Ventilation Volume

研究概览

简要总结

This is a before-and-after study examining the impact of real-time ventilation monitoring during out-of-hospital cardiac arrest. Study investigators will compare ventilation quality (rate, volume) performed during the resuscitation without the real-time feedback (before phase), to ventilation quality with the use of real-time feedback using the Zoll Accuvent device (after phase).

详细描述

The before intervention phase of this study will involve no change in practice to cardiac resuscitation by paramedics. Paramedics will be instructed to attach the Zoll AccuVent® to the BVM at each use and to leave it attached throughout the duration of the resuscitation.

During the resuscitation the Zoll AccuVent® will monitor and record ventilation rates and volumes that are being delivered during each ventilation performed utilizing the "Real BVM Help®" dashboard, however rescuers will be blinded to this information and will not be able to access it during the resuscitation. Post-call paramedics will upload the Zoll file containing the ventilation data in addition to CPR quality data and cardiac rhythms. This is consistent with current standard practice. These files will then be used by study investigators for data analysis. During this initial phase, to avoid biasing the study results the paramedics will only be trained on application of the Zoll AccuVent®, but will not have access to the real-time dashboard.

The study intervention will involve a brief training session for paramedics during the annual continuing medical education (CME) day. Training will consist of specifics of the study as well as how to apply the Zoll AccuVent® device and use the device during a cardiac arrest. Paramedics will be reminded of good ventilation practices during cardiac arrest and post-cardiac arrest care as well as current standards of practice as defined by the American Heart Association and Heart and Stroke Foundation of Canada.

Post-intervention, paramedics will be "un-blinded" and able to utilize the real-time feedback from the Zoll AccuVent® to help guide the delivery of ventilations during cardiac arrest resuscitation. All other aspects of care will be provided in accordance with standard practice at that time. Once the Zoll AccuVent® is applied, paramedics will use the real-time monitoring capabilities of the device to monitor the delivery of ventilations (rate and volume) during the resuscitation. Post-call paramedics will again upload files containing ventilation data that study investigators will analyze to compare our results.

Bivariate descriptive statistics will be used to examine differences in ventilation parameters between paramedics while using the Zoll AccuVent® and using standard monitoring devices (standard of care). The mean volume (mL) will be calculated for each of the two groups and Student's t-test will be used to compare the mean difference in volume (mL) between groups. Investigators will compare the proportion of ventilations per minute that are compliant with AHA guideline recommendations using Chi-square test for proportions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult out-of-hospital cardiac arrests treated by paramedics

排除标准

  • traumatic cardiac arrest
  • prehospital Do Not Resuscitate (DNR) orders

结局指标

主要结局

Ventilation Volume

时间窗: Day 1

Measurement of the volume of ventilation (mL) during resuscitation

次要结局

  • Feasibility of successfully using Zoll Accuvent device in the field Feasibility(Day 1)
  • Ventilation Rate(Day 1)
  • Prehospital Return of spontaneous circulation (ROSC)(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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