Assessment of Thermal Condition of Health Workers Who Use... | NCT04427267

Studies
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients

NCT04427267

Sponsor

Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

Status

Completed

Last Update Posted

Jul 28, 2020Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients

Interventions

Personal protective equipment from biological hazard

Countries

Russia

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

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2020Actual

Primary Completion Date

Jun 27, 2020Actual

Completion Date

Jun 27, 2020Actual

First Submitted Date

Jun 10, 2020

First Submission Date that Met QC Criteria

Jun 10, 2020

First Posted Date

Jun 11, 2020Actual

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

Jul 27, 2020

Last Update Posted Date

Jul 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrey Mikhailovich Geregey, Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"Principal Investigator

Lead Sponsor

Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes.

This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health workers			Other: Personal protective equipment from biological hazard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Personal protective equipment from biological hazard	Other	Includes: isolation clothing, mask, eyewear, overshoes	Health workers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin thermometry	DS1923-F5 Thermochron iButtons	6 hours
Hygrometry under costume	DS1923-F5 Thermochron iButtons	6 hours
Heart rate	A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research	6 hours
Air thermometry	Meteoscop - M	6 hours
Air hygrometry	Meteoscop - M	6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals (based on medical screening)

Exclusion Criteria:

endocrinological diseases and disorders
health deviations at the time of the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Health workers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health		Moscow		105275	Russia

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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases