Thermoregulatory Reactions of Medical Workers Who Use Personal Protective Equipment From Biological Hazards

October 12, 2021 updated by: Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

Study of Thermoregulatory Reactions of the Body of Medical Workers Who Use Personal Protective Equipment From Biological Hazards

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research will recruit 14-20 volunteers. During 8 hours each subject will perform their work using protective costume. Heart rate, electrocardiogram, oxygenation, 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 and assessment of working conditions.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 105275
        • Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health workers

Description

Inclusion Criteria:

  • healthy individuals (based on medical screening)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health workers
Medical personnel: doctors, nurses.
Other: Personal protective equipment from biological hazard
Includes: isolation clothing, mask, eyewear, overshoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin thermometry
Time Frame: 8 hours
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
8 hours
Hygrometry under costume
Time Frame: 8 hours
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
8 hours
Electrocardiography
Time Frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia), all parameters.
8 hours
Blood pressure
Time Frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
8 hours
Heart rate
Time Frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
8 hours
Breathing rate
Time Frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
8 hours
Air thermometry and hygrometry
Time Frame: 8 hours
"METEOSCOP-M" (LLC "NTM-Zashchita", Russia)
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 8 hours
Pulse oximeter MD300C2 ("Choicemmed", China)
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alexey Konyukhov, Junior scientist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPE-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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