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

NCT ID: NCT04915560

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2023-11-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Work-Related Condition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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ORTEC Employee

ORTEC professional employees performing an industrial cleaning task.

Group Type EXPERIMENTAL

Connected T-shirt

Intervention Type DEVICE

Ware of a connected T-shirt

Interventions

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Connected T-shirt

Ware of a connected T-shirt

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ortec International

INDUSTRY

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir HENNI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2021-A01390-41

Identifier Type: -

Identifier Source: org_study_id

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