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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04427267
Other study ID # PPE-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 3, 2020
Est. completion date June 27, 2020

Study information

Verified date July 2020
Source Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date June 27, 2020
Est. primary completion date June 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy individuals (based on medical screening)

Exclusion Criteria:

- endocrinological diseases and disorders

- health deviations at the time of the study

Study Design


Intervention

Other:
Personal protective equipment from biological hazard
Includes: isolation clothing, mask, eyewear, overshoes

Locations

Country Name City State
Russian Federation Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

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