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Clinical Trials/NCT04915560
NCT04915560
Withdrawn
N/A

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 site in 1 countryJune 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Work-Related Condition
Sponsor
University Hospital, Angers
Locations
1
Primary Endpoint
Feasibility of T-shirt recording
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2021
End Date
November 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Feasibility of T-shirt recording

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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