Healthy AdultNCT07726537
Testing of Personal Protective Equipment (PPE) for First Responders
A study testing Category III PPE suit "COMAT (Matisec, France)" and Category III PPE Suit "EBO-10 (EGO, Czech Republic)" in people with Healthy Adult, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of this pilot study is to improve protection of first responders in case of biological disasters (e.g., pandemics, biotoxin incidents). For this goal we will compare two different kinds of personal protective equipment (PPE) to be used for a variety of exercises simulating activities of first responders in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Category III PPE suit "COMAT (Matisec, France)" and Category III PPE Suit "EBO-10 (EGO, Czech Republic)"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 17 Jul 2026to 17 Oct 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will be open to employees or students of:
- the KAGES hospital, Graz, Austria
- the Medical University of Graz (Med Uni Graz), Austria
- the University of Graz, Austria
- the Red Cross
- the Police
- Fire brigade of the city of Graz
Who cannot join
- Pregnancy, allergy against latex or PVC, claustrophobia, acute infection, thrombophilia
- Chronic illnesses (not treated) such as asthma, COPD, cardiovascular diseases, diabetes mellitus and epilepsy,
- Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to improve protection of first responders in case of biological disasters (e.g., pandemics, biotoxin incidents). For this goal we will compare two different kinds of personal protective equipment (PPE) to be used for a variety of exercises simulating activities of first responders in the field at two different environmental temperature profiles in a randomized cross-over study design. The goal is to find the best possible compromise between protection and ergonomics as well as to determine potential factors that might limit the performance of first responders while wearing PPE. This should provide guidance for future improvement of PPE and how biosensors for monitoring heart rate and body temperature in combination with AI models may reduce risk for first responders in the field.
Read the detailed description
During three cycles of simulated work physiological parameters such as heart rate, body temperature and fluid loss as well as fine motor skills, error rate and reaction time will be monitored, complemented with a questionnaire on comfort and wellbeing after each cycle.
- Conditions
- Healthy Adult
- Being tested
- Category III PPE suit "COMAT (Matisec, France)", Category III PPE Suit "EBO-10 (EGO, Czech Republic)"
- Keywords
- Personal protective equipment, physiological parameters, biosensor, first responder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Category III PPE suit "COMAT (Matisec, France)"Other
3 cycles of 6 different tasks at 2 different temperatures will be performed wearing the following Category III PPE suit: COMAT from Matisec, France. This suit will be worn with a face mask (Draeger) equipped with a P3 filter, as well as rubber boots and 2 layers of nitrile gloves.
Category III PPE Suit "EBO-10 (EGO, Czech Republic)"Other
3 cycles of 6 different tasks at 2 different temperatures will be performed wearing the following Category III PPE suit: EBO-10 from EGO, Czech Republic. This suit is a full body ventilated suit with powered air purifying respirators, and will be worn with rubber boots and 2 layers of nitrile gloves.
| Study group | Role | What they receive |
|---|---|---|
| Simulated tasks performed at 20-24°C | Experimental | Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 20-24°C Receives: Other: Category III PPE suit "COMAT (Matisec, France)"; Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)" |
| Simulated tasks performed at 30-34°C | Experimental | Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 30-34°C Receives: Other: Category III PPE suit "COMAT (Matisec, France)"; Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Mean change in body weight (kg) after completion/termination of the test
Measured: Baseline and at completion/termination (max. 6 hours after start)
Heart rate
Heart rate is measured using a blood pressure cuff before and after the test, as well as using sensors strapped next to the skin during the test.
Measured: Baseline, continuously during the test, and after completion of test (max 6 hours)
Blood pressure
Blood pressure is measured using a blood pressure cuff.
Measured: Baseline and after completion of test (max 6 hours)
Weight of Category III PPE suit
Weight of suit in kg at before and after the test to assess fluid loss.
Measured: Baseline and after completion of test (max 6 hours)
Body temperature
Body temperature in °C is measured using an in-ear thermometer before and after the test, as well as using sensors next to the skin during the test.
Measured: Baseline, during the test, and after completion of test (max 6 hours)
Humidity
Humidity is measured using sensors next to the skin.
Measured: For the duration of the test (max 6 hours)
Mean reaction time
Reaction time is measured using the ReactionX app, with 4 sensors that light up intermittently.
Measured: 10 minutes
Semi-quantitative questionnaire on subjective wellbeing
The questionnaire uses a scale of 0-10 and is the last task in each of the 3 cycles of 6 tasks.
Measured: 5 min
Resilience scale questionnaire RS-13
The internationally standardized questionnaire assesses psychological stress level, using a scale of 0-7 (do not agree - completely agree). It is completed before starting the test, and after completion or termination of test (after max 6 hours).
Measured: 5 min
Error rate
Error rate is assessed by matching coloured and numbered caps to matching tubes and sorting them into predefined positions into a 81-position sample box. Number of errors is documented.
Measured: Max 20 min
Fine motor skills
Fine motor skills are assessed by matching coloured and numbered caps to matching tubes and sorting them into predefined positions in an 81-position sample box. Time needed to complete the task is documented.
Measured: Max 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start17 Jul 2026
- Primary completion17 Oct 2026
- Study completion17 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will test 2 different Category III PPE suits in random order at two different temperatures (20-24°C and at 30-34°C).
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Kurt Zatloukal, Medical University of Graz
- Investigators
- Kurt Zatloukal, Principal investigator, Med Uni Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726537
- Sponsor's protocol ID
- 1168_2026
- Other IDs
- 101168322 - EMBRACE
- Status last verified
- Nov 2026
- First submitted
- 15 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loibner M, Hagauer S, Schwantzer G, Berghold A, Zatloukal K. Limiting factors for wearing personal protective equipment (PPE) in a health care environment evaluated in a randomised study. PLoS One. 2019 Jan 22;14(1):e0210775. doi: 10.1371/journal.pone.0210775. eCollection 2019.
PubMed 30668567
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Personal Protective Equipment (PPE) for First Responders
- ClinicalTrials.gov ID
- NCT07726537
- Acronym / sponsor ID
- 1168_2026
- Conditions
- Healthy Adult
- Keywords
- Personal protective equipment, physiological parameters, biosensor, first responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 17 Oct 2026 (actual)
- Study completion
- 17 Oct 2026 (actual)
- First posted
- 24 Jul 2026 (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.
The purpose of this pilot study is to improve protection of first responders in case of biological disasters (e.g., pandemics, biotoxin incidents). For this goal we will compare two different kinds of personal protective equipment (PPE) to be used for a variety of exercises simulating activities of first responders in the field at two different environmental temperature profiles in a randomized cross-over study design. The goal is to find the best possible compromise between protection and ergonomics as well as to determine potential factors that might limit the performance of first responders while wearing PPE. This should provide guidance for future improvement of PPE and how biosensors for monitoring heart rate and body temperature in combination with AI models may reduce risk for first responders in the field.
Detailed description
During three cycles of simulated work physiological parameters such as heart rate, body temperature and fluid loss as well as fine motor skills, error rate and reaction time will be monitored, complemented with a questionnaire on comfort and wellbeing after each cycle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will test 2 different Category III PPE suits in random order at two different temperatures (20-24°C and at 30-34°C).
| Arm | Type | Receives |
|---|---|---|
| Simulated tasks performed at 20-24°C | Experimental | Other: Category III PPE suit "COMAT (Matisec, France)", Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)"Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 20-24°C |
| Simulated tasks performed at 30-34°C | Experimental | Other: Category III PPE suit "COMAT (Matisec, France)", Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)"Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 30-34°C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- the KAGES hospital, Graz, Austria
- the Medical University of Graz (Med Uni Graz), Austria
- the University of Graz, Austria
- the Red Cross
- the Police
Key exclusion criteria (3 listed)
- Pregnancy, allergy against latex or PVC, claustrophobia, acute infection, thrombophilia
- Chronic illnesses (not treated) such as asthma, COPD, cardiovascular diseases, diabetes mellitus and epilepsy,
- Participation in another 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 |
|---|---|---|
| Category III PPE suit "COMAT (Matisec, France)"3 cycles of 6 different tasks at 2 different temperatures will be performed wearing the following Category III PPE suit: COMAT from Matisec, France. This suit will be worn with a face mask (Draeger) equipped with a P3 filter, as well as rubber boots and 2 layers of nitrile gloves. | Other | Simulated tasks performed at 20-24°C, Simulated tasks performed at 30-34°C |
| Category III PPE Suit "EBO-10 (EGO, Czech Republic)"3 cycles of 6 different tasks at 2 different temperatures will be performed wearing the following Category III PPE suit: EBO-10 from EGO, Czech Republic. This suit is a full body ventilated suit with powered air purifying respirators, and will be worn with rubber boots and 2 layers of nitrile gloves. | Other | Simulated tasks performed at 20-24°C, Simulated tasks performed at 30-34°C |
Primary outcome
Body weight
Time frame: Baseline and at completion/termination (max. 6 hours after start)
Mean change in body weight (kg) after completion/termination of the test
Heart rate
Time frame: Baseline, continuously during the test, and after completion of test (max 6 hours)
Heart rate is measured using a blood pressure cuff before and after the test, as well as using sensors strapped next to the skin during the test.
Blood pressure
Time frame: Baseline and after completion of test (max 6 hours)
Blood pressure is measured using a blood pressure cuff.
Weight of Category III PPE suit
Time frame: Baseline and after completion of test (max 6 hours)
Weight of suit in kg at before and after the test to assess fluid loss.
Body temperature
Time frame: Baseline, during the test, and after completion of test (max 6 hours)
Body temperature in °C is measured using an in-ear thermometer before and after the test, as well as using sensors next to the skin during the test.
Humidity
Time frame: For the duration of the test (max 6 hours)
Humidity is measured using sensors next to the skin.
Mean reaction time
Time frame: 10 minutes
Reaction time is measured using the ReactionX app, with 4 sensors that light up intermittently.
Semi-quantitative questionnaire on subjective wellbeing
Time frame: 5 min
The questionnaire uses a scale of 0-10 and is the last task in each of the 3 cycles of 6 tasks.
Resilience scale questionnaire RS-13
Time frame: 5 min
The internationally standardized questionnaire assesses psychological stress level, using a scale of 0-7 (do not agree - completely agree). It is completed before starting the test, and after completion or termination of test (after max 6 hours).
Error rate
Time frame: Max 20 min
Error rate is assessed by matching coloured and numbered caps to matching tubes and sorting them into predefined positions into a 81-position sample box. Number of errors is documented.
Fine motor skills
Time frame: Max 20 min
Fine motor skills are assessed by matching coloured and numbered caps to matching tubes and sorting them into predefined positions in an 81-position sample box. Time needed to complete the task is documented.
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 4 Nov 2026.
- Background: PubMed 30668567Loibner M, Hagauer S, Schwantzer G, Berghold A, Zatloukal K. Limiting factors for wearing personal protective equipment (PPE) in a health care environment evaluated in a randomised study. PLoS One. 2019 Jan 22;14(1):e0210775. doi: 10.1371/journal.pone.0210775. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Kurt Zatloukal principal investigator
Med Uni Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Category III PPE suit "COMAT (Matisec, France)" and Category III PPE Suit "EBO-10 (EGO, Czech Republic)" in people with Healthy Adult, run by Medical University of Graz at 1 site in Austria.
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 7 inclusion and 3 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 4 Nov 2026. 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 Austria. 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?
Body weight (time frame: Baseline and at completion/termination (max. 6 hours after start)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726537, which also lists 1 linked publication.
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 4 Nov 2026.