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临床试验/NCT03730025
NCT03730025已完成不适用

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study

University Hospital Padova1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月2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
60
试验地点
1
主要终点
Timing of the first HR communication.

研究概览

简要总结

NeoTapAdvancedSupport (NeoTapAS) is a free-of-charge mobile application that showed good accuracy in HR estimation. This study aims to evaluate the impact of NeoTapAS on timing of HR communication and of resuscitation interventions in a high fidelity simulation scenario.

详细描述

Assessing the HR by auscultation can be limited due to imprecise auscultation and/or errors in mental computation, leading to inappropriate or delayed resuscitation. Previous studies evaluated a free-of-charge mobile application (NeoTapAdvancedSupport, NeoTapAS) to help HR assessment in a simulated scenario of neonatal resuscitation. NeoTapAS showed good accuracy in estimating HR and could be a useful tool in resource-constrained settings.

Another potential advantage of using NeoTapAS may be the anticipation of HR communication during resuscitation, because it avoids mental computation and possible errors due to the stressful situation. In addition, prompt HR assessment may lead to anticipating resuscitation interventions. However, these hypotheses remain to be demonstrated.

The aim of this study is to evaluate the promptness in HR communication using NeoTapAS compared with mental computation in a high-fidelity simulated newborn resuscitation scenario. In addition, the impact of NeoTapAS on timing of resuscitation procedures will be investigated.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation

排除标准

  • Lack of EC approval
  • Lack of consent to record the scenario and to use the data

结局指标

主要结局

Timing of the first HR communication.

时间窗: 1 min

Time elapsed from birth to the first HR communication

次要结局

  • Timing of the fifth HR communication(5 min)
  • Timing of the fourth HR communication(4 min)
  • Timing of the second HR communication(2 min)
  • Timing of the third HR communication(3 min)
  • Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline(10 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Trevisanuto

Professor

University Hospital Padova

研究点 (1)

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