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临床试验/NCT04548934
NCT04548934已完成不适用

Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic

Institute of Mountain Emergency Medicine2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Depth of chest compression

研究概览

简要总结

Background The significant risk of transmission of SARS-CoV-2 to healthcare staff mandated changes to Basic and Advanced Life Support (BLS and ALS) guidelines. As advised by the European Resuscitation Council (ERC), healthcare staff should put on airborne-precaution personal protective equipment (PPE) before starting chest compressions and/or airway interventions, as a minimum an FFP3 mask (FFP2 or N95 if FFP3 not available), eye and face protection and long-sleeved gown. However, wearing FFP3 masks has been shown to highly impair cardiopulmonary exercise capacity and the effect of wearing PPE on the quality of cardiopulmonary resuscitation is not known. The aim of this project is therefore to to investigate whether wearing PPE has an effect on the quality of chest compressions.

Methods The study forsees a simulated CPR scenario on manikins. Study participants are lay rescuers and members of the rescue organization Croce Bianca. Each participant will perform 5 sequences consisting of 2 min of chest compressions altered by 2 min of no chest compressions (break), as recommended by the current ERC guidelines. The participants will perform the described CPR sequence two times in a cross-over design with randomized order, once while wearing PPE and once without wearing PPE. Between the two CPR sequences (i.e. with and without PPE) a break of 60 min for recovery will be given. During both CPR sequences, the quality of chest compressions will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Member of the rescue organization "Croce Bianca"
  • Aged 18-60
  • Certified in basic life support (BLS)
  • No current COVID-19 symptoms, not being tested positive for COVID-19, no COVID-19 symptoms in the 4 weeks before the tests, no quarantine or unprotected contacts with COVID positive patients in the last 4 weeks, body temperature ≤ 37.5°on test days.
  • Obtained informed consent.

排除标准

  • Age <16 or >60 years,
  • No informed consent
  • Current COVID-19 symptoms, being tested positive for COVID 19 or symptoms in the 4 weeks before the tests, quarantine or unprotected contacts with COVID-19 positive patients in the last 4 weeks, body temperature ≥ 37.5°on test days.

结局指标

主要结局

Depth of chest compression

时间窗: 20 minutes of CPR

Difference in chest compression depth during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).

次要结局

  • Relaxation(20 minutes of CPR)
  • Chest compression rate(20 minutes of CPR)

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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