OverheatingNCT05091515
Thermoregulatory Reactions of Medical Workers Who Use Personal Protective Equipment From Biological Hazards
An observational study of Overheating, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overheating
- What is being tested?
- Personal protective equipment from biological hazard
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 29 Mar 2021to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Health workers
Who may be able to join
- healthy individuals (based on medical screening)
Who cannot join
- endocrinological diseases and disorders
- health deviations at the time of the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Moscow, 105275
About this study
Official title: 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.
Read the 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.
- Conditions
- Overheating
- Being tested
- Personal protective equipment from biological hazard
- Keywords
- Thermophysiology, Personal protective equipment from biological hazards, Medical workers, COVID-19, Working conditions
- Medical subject headings
- Sunstroke, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal protective equipment from biological hazardOther
Includes: isolation clothing, mask, eyewear, overshoes
| Study group | Role | What they receive |
|---|---|---|
| Health workers | Medical personnel: doctors, nurses. Receives: Other: Personal protective equipment from biological hazard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin thermometry
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
Measured: 8 hours
Hygrometry under costume
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
Measured: 8 hours
Electrocardiography
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia), all parameters.
Measured: 8 hours
Blood pressure
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Measured: 8 hours
Heart rate
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Measured: 8 hours
Breathing rate
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Measured: 8 hours
Air thermometry and hygrometry
"METEOSCOP-M" (LLC "NTM-Zashchita", Russia)
Measured: 8 hours
Secondary outcomes (1)
Oxygenation
Pulse oximeter MD300C2 ("Choicemmed", China)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start29 Mar 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverheatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
- Investigators
- Alexey Konyukhov, Principal investigator, Junior scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091515
- Sponsor's protocol ID
- PPE-05
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thermoregulatory Reactions of the Body of Medical Workers Who Use Personal Protective Equipment From Biological Hazards
- ClinicalTrials.gov ID
- NCT05091515
- Acronym / sponsor ID
- PPE-05
- Conditions
- Overheating
- Keywords
- Thermophysiology, Personal protective equipment from biological hazards, Medical workers, COVID-19, Working conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"University, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health workers | – | Other: Personal protective equipment from biological hazardMedical personnel: doctors, nurses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health workers
Key inclusion criteria (1 listed)
- healthy individuals (based on medical screening)
Key exclusion criteria (2 listed)
- endocrinological diseases and disorders
- health deviations at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal protective equipment from biological hazardIncludes: isolation clothing, mask, eyewear, overshoes | Other | Health workers |
Primary outcome
Skin thermometry
Time frame: 8 hours
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
Hygrometry under costume
Time frame: 8 hours
DS1923-F5 Thermochron iButtons ("MaximIntegratedProducts, Inc", USA)
Electrocardiography
Time frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia), all parameters.
Blood pressure
Time frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Heart rate
Time frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Breathing rate
Time frame: 8 hours
Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Air thermometry and hygrometry
Time frame: 8 hours
"METEOSCOP-M" (LLC "NTM-Zashchita", Russia)
1 secondary outcome
Oxygenation
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Konyukhov principal investigator
Junior scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overheating, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin thermometry (time frame: 8 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.