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

Overheating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091515
• Other study ID #: PPE-05
• Status: Completed
• Start date: March 29, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2021
• Source: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy individuals (based on medical screening)

Exclusion Criteria:

• endocrinological diseases and disorders

• health deviations at the time of the study

Related Conditions & MeSH terms

• Heat Stroke
• Overheating

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 ("MaximIntegratedProducts, Inc", USA)	8 hours
Primary	Hygrometry under costume	DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)	8 hours
Primary	Electrocardiography	Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia), all parameters.	8 hours
Primary	Blood pressure	Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)	8 hours
Primary	Heart rate	Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)	8 hours
Primary	Breathing rate	Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)	8 hours
Primary	Air thermometry and hygrometry	"METEOSCOP-M" (LLC "NTM-Zashchita", Russia)	8 hours
Secondary	Oxygenation	Pulse oximeter MD300C2 ("Choicemmed", China)	8 hours