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临床试验/NCT04904770
NCT04904770已完成不适用

Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization: Open-Label Simulation-based Randomized Controlled Trial

Stuby Loric2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Change in time to perform the procedure

研究概览

简要总结

A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress.

详细描述

A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress. The participants will be recruited among healthcare workers from one Emergency Medical Service. Then, the participants will first act as patient and undergo spinal stabilization from an other team, afterwards they will have to complete a spinal stabilization either using a scoop stretcher or a vacuum mattress, depending on allocation regarding randomization. The sessions will be video recorded to allow subsequent assessment.

研究设计

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

盲法说明

Due to nature of therapy, it is impossible to mask participants, care provider, investigators or outcomes assessors. Statistician will however be blinded to allocation.

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

  • registered paramedics or emergency medical technician (EMT) actually working in the ambulance service.

排除标准

  • member of study investigators

研究组 & 干预措施

Vacuum mattress

Active Comparator

A vacuum mattress will be used as device to perform spinal stabilization

干预措施: Vacuum mattress (Device)

Scoop stretcher

Experimental

A scoop stretcher will be used as device to perform spinal stabilization

干预措施: Scoop stretcher (Device)

结局指标

主要结局

Change in time to perform the procedure

时间窗: At study session (real-time assessment), in July or August

The time required to complete the procedure from the team leader's order to start, until the device is left up from the ground, measured in seconds.

次要结局

  • Quality of stabilization(At study session (real-time assessment), in July or August)
  • Level of anxiety(5 minutes after spinal stabilization, on a questionnaire)
  • Level of comfort(5 minutes after spinal stabilization, on a questionnaire)
  • Degree of induced dyspnoea or shortness of breath(5 minutes after spinal stabilization, on a questionnaire)

研究者

发起方
Stuby Loric
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stuby Loric

Principal Investigator

Geneve TEAM Ambulances

研究点 (2)

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