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临床试验/NCT04915560
NCT04915560撤回不适用

Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.

University Hospital, Angers1 个研究点 分布在 1 个国家开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Feasibility of T-shirt recording

研究概览

简要总结

The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning

详细描述

A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.

On the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.

The number and causes of alarms are determined after the end of the cleaning task.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
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

  • Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
  • Affiliation to the French National healthcare system
  • French speaking employee

排除标准

  • Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)
  • Pregnancy
  • Inability to understand the study goal
  • Employee protected by decision of law

结局指标

主要结局

Feasibility of T-shirt recording

时间窗: 12 months

Percentage of valid data from connected T-Shirt. The physiological data is fed back to an integrator and values for respiratory rate (FR), heart rate (HR), temperature (T °) and activity index are calculated over a period of 5 minutes. These values are only calculated if 15% of the raw data can be used over each period of 5 minutes.

次要结局

  • Percentage of alarms processed in less than 3 minutes(12 months)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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