Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 PatientsNCT04427267
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
An observational study of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients, 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 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
- What is being tested?
- Personal protective equipment from biological hazard
- How many people
- 6 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jun 2020to 27 Jun 2020
- 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 45 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: Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients
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.
- Being tested
- Personal protective equipment from biological hazard
- Keywords
- Thermophysiology, Personal protective equipment from biological hazards, Medical workers, COVID-19
- Medical subject headings
- 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 | Not described 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
Measured: 6 hours
Hygrometry under costume
DS1923-F5 Thermochron iButtons
Measured: 6 hours
Heart rate
A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Measured: 6 hours
Air thermometry
Meteoscop - M
Measured: 6 hours
Air hygrometry
Meteoscop - M
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Jun 2020
- Primary completion27 Jun 2020
- Study completion27 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 PatientsStudies 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
- 6 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"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427267
- Sponsor's protocol ID
- PPE-02
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04427267
- Acronym / sponsor ID
- PPE-02
- Keywords
- Thermophysiology, Personal protective equipment from biological hazards, Medical workers, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"University, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 27 Jun 2020 (actual)
- First posted
- 11 Jun 2020 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health workers | – | Other: Personal protective equipment from biological hazard |
Who may qualify
- Ages
- 18 to 45 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: 6 hours
DS1923-F5 Thermochron iButtons
Hygrometry under costume
Time frame: 6 hours
DS1923-F5 Thermochron iButtons
Heart rate
Time frame: 6 hours
A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
Air thermometry
Time frame: 6 hours
Meteoscop - M
Air hygrometry
Time frame: 6 hours
Meteoscop - M
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 28 Jul 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients, 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 28 Jul 2020. 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: 6 hours). The study lists 5 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 28 Jul 2020.