Feasibility of a Physiological Monitoring for Teleassista... | NCT04915560

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

NCT04915560

Sponsor

University Hospital, Angers

Status

Withdrawn

Last Update Posted

May 25, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Work-Related Condition

Interventions

Connected T-shirt

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The French committee refused the amendment.

Expanded Access Info

Start Date

Jun 9, 2021Actual

Primary Completion Date

Oct 15, 2023Estimated

Completion Date

Nov 15, 2023Estimated

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 25, 2023Actual

Name	Class
Ortec International	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ORTEC Employee	Experimental	ORTEC professional employees performing an industrial cleaning task.	Device: Connected T-shirt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Connected T-shirt	Device	Ware of a connected T-shirt	ORTEC Employee

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samir HENNI, MD, PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU		Angers			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided