- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07726537
Testing of Personal Protective Equipment (PPE) for First Responders
July 21, 2026 updated by: Kurt Zatloukal, Medical University of Graz
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kurt Zatloukal, Dr. med.
- Phone Number: +436641533264
- Email: kurt.zatloukal@medunigraz.at
Study Contact Backup
- Name: Julia Kircher
- Email: julia.kircher@medunigraz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- Recruiting
- Medical University of Graz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
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.
|
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and at completion/termination (max. 6 hours after start)
|
|
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.
|
Baseline, continuously during the test, and after completion of test (max 6 hours)
|
|
Blood pressure
Time Frame: Baseline and after completion of test (max 6 hours)
|
Blood pressure is measured using a blood pressure cuff.
|
Baseline and after completion of test (max 6 hours)
|
|
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.
|
Baseline and after completion of test (max 6 hours)
|
|
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.
|
Baseline, during the test, and after completion of test (max 6 hours)
|
|
Humidity
Time Frame: For the duration of the test (max 6 hours)
|
Humidity is measured using sensors next to the skin.
|
For the duration of the test (max 6 hours)
|
|
Mean reaction time
Time Frame: 10 minutes
|
Reaction time is measured using the ReactionX app, with 4 sensors that light up intermittently.
|
10 minutes
|
|
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.
|
5 min
|
|
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).
|
5 min
|
|
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.
|
Max 20 min
|
|
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.
|
Max 20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kurt Zatloukal, Med Uni Graz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
July 15, 2026
First Submitted That Met QC Criteria
July 21, 2026
First Posted (Actual)
July 24, 2026
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1168_2026
- 101168322 - EMBRACE (Other Grant/Funding Number: EUROPEAN RESEARCH EXECUTIVE AGENCY (REA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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