NCT04427267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

24 days

First QC Date

June 10, 2020

Last Update Submit

July 27, 2020

Conditions

Keywords

ThermophysiologyPersonal protective equipment from biological hazardsMedical workersCOVID-19

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Health workers

Other: Personal protective equipment from biological hazard

Interventions

Includes: isolation clothing, mask, eyewear, overshoes

Health workers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Health workers

You may qualify if:

  • healthy individuals (based on medical screening)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, 105275, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 11, 2020

Study Start

June 3, 2020

Primary Completion

June 27, 2020

Study Completion

June 27, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations