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NCT04915560 Clinical Trial

Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning

Work-Related Condition Clinical Trial

— TIGER  

Official title:
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.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04915560
Other study ID # 2021-A01390-41
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 9, 2021
Est. completion date November 15, 2023

Study information
Verified date May 2023
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 15, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Connected T-shirt
Ware of a connected T-shirt

Locations
Country Name City State
France CHU Angers

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Angers Ortec International

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of T-shirt recording 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. 12 months
Secondary Percentage of alarms processed in less than 3 minutes Number of alarms processed in less than 3 minutes 12 months
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