NCT05091515

Brief Summary

This research will provide data on thermal condition, functional status and working conditions of medical workers who use personal protective equipment from biological hazards. Acquired data will be used to define acceptable period of use for these protective costumes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

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

March 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

August 24, 2021

Last Update Submit

October 12, 2021

Conditions

Overheating

Keywords

ThermophysiologyPersonal protective equipment from biological hazardsMedical workersCOVID-19Working conditions

Outcome Measures

Primary Outcomes (7)

  • Skin thermometry

    DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)

    8 hours

  • Hygrometry under costume

    DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)

    8 hours

  • Electrocardiography

    Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia), all parameters.

    8 hours

  • Blood pressure

    Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)

    8 hours

  • Heart rate

    Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)

    8 hours

  • Breathing rate

    Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)

    8 hours

  • Air thermometry and hygrometry

    "METEOSCOP-M" (LLC "NTM-Zashchita", Russia)

    8 hours

Secondary Outcomes (1)

  • Oxygenation

    8 hours

Study Arms (1)

Health workers

Medical personnel: doctors, nurses.

Other: Personal protective equipment from biological hazard

Interventions

Personal protective equipment from biological hazardOTHER

Includes: isolation clothing, mask, eyewear, overshoes

Health workers

Eligibility Criteria

Age18 Years - 55 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

SunstrokeCOVID-19

Condition Hierarchy (Ancestors)

Heat StrokeHeat Stress DisordersWounds and InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alexey Konyukhov

    Junior scientist

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

August 24, 2021

First Posted

October 25, 2021

Study Start

March 29, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations

RU(1)