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RecruitingNCT07726537Updated Jul 24, 2026

Testing of Personal Protective Equipment (PPE) for First Responders

An interventional study of Category III PPE suit "COMAT (Matisec, France)" and Category III PPE Suit "EBO-10 (EGO, Czech Republic)" in Healthy Adult, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Adult

Keywords

  • Personal protective equipment
  • physiological parameters
  • biosensor
  • first responder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Simulated tasks performed at 20-24°C

    Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 20-24°C

    Other: Category III PPE suit "COMAT (Matisec, France)" · Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)"

  • Experimental
    Simulated tasks performed at 30-34°C

    Participants wearing Category III PPE suit 1 or 2 perform 3 cycles of 6 tasks at 30-34°C

    Other: Category III PPE suit "COMAT (Matisec, France)" · Other: Category III PPE Suit "EBO-10 (EGO, Czech Republic)"

Interventions

  • OtherCategory 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.

  • OtherCategory 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.

05

What researchers measure

Primary outcomes

  1. Body weight

    Mean change in body weight (kg) after completion/termination of the test

    Time frame: Baseline and at completion/termination (max. 6 hours after start)

  2. 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.

    Time frame: Baseline, continuously during the test, and after completion of test (max 6 hours)

  3. Blood pressure

    Blood pressure is measured using a blood pressure cuff.

    Time frame: Baseline and after completion of test (max 6 hours)

  4. Weight of Category III PPE suit

    Weight of suit in kg at before and after the test to assess fluid loss.

    Time frame: Baseline and after completion of test (max 6 hours)

  5. 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.

    Time frame: Baseline, during the test, and after completion of test (max 6 hours)

  6. Humidity

    Humidity is measured using sensors next to the skin.

    Time frame: For the duration of the test (max 6 hours)

  7. Mean reaction time

    Reaction time is measured using the ReactionX app, with 4 sensors that light up intermittently.

    Time frame: 10 minutes

  8. 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.

    Time frame: 5 min

  9. 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).

    Time frame: 5 min

  10. 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.

    Time frame: Max 20 min

  11. 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.

    Time frame: Max 20 min

06

Study locations

1 of 1 sites recruiting
  • Medical University of Graz
    Graz, Styria 8010, Austria
    Recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07726537
Lead sponsor
Medical University of Graz
Collaborators
European Union
Responsible party
Kurt Zatloukal (Prof. Dr. med. of Pathology, Medical University of Graz) — Principal investigator
First posted
Jul 24, 2026
Start date
Jul 17, 2026
Primary completion
Aug 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Kurt Zatloukal, Dr. med.
Contact
kurt.zatloukal@medunigraz.at
+436641533264
Julia Kircher
Contact
julia.kircher@medunigraz.at
Kurt Zatloukal
principal investigator · Med Uni Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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