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

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.

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

Study Overview

• Status: Withdrawn
• Conditions: Work-Related Condition
• Intervention / Treatment: Device: Connected T-shirt

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ORTEC Employee; ORTEC professional employees performing an industrial cleaning task.	Device: Connected T-shirt; Ware of a connected T-shirt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of alarms processed in less than 3 minutes	Number of alarms processed in less than 3 minutes	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Ortec International
• Investigators: Principal Investigator: Samir HENNI, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Estimated): October 15, 2023
• Study Completion (Estimated): November 15, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01390-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No