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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Work-Related Condition

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