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

Not Applicable

Withdrawn

• Conditions: Work-Related Condition
• Interventions: Device: Connected T-shirt

• Registration Number: NCT04915560
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Study Start: 2021-06-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2023-10-15
• Study Completion: 2023-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ORTEC Employee	Connected T-shirt	ORTEC professional employees performing an industrial cleaning task.

Primary Outcome Measures

Name	Time	Method
Feasibility of T-shirt recording	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 Outcome Measures

Name	Time	Method
Percentage of alarms processed in less than 3 minutes	12 months	Number of alarms processed in less than 3 minutes

Trial Locations

Locations (1)

CHU; 🇫🇷 Angers, France