Testing of Personal Protective Equipment (PPE) for First Responders

NCT07726537 | Recruiting

• 2 other identifiers: 1168_2026101168322 - EMBRACE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult

Keywords

Personal protective equipment; physiological parameters; biosensor; first responder

Outcome Measures

Primary Outcomes (11)

• Body weight

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

  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.

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

• Blood pressure

  Blood pressure is measured using a blood pressure cuff.

  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.

  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.

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

• Humidity

  Humidity is measured using sensors next to the skin.

  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.

  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.

  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).

  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.

  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.

  Max 20 min

Study Arms (2)

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

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

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

Interventions

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.

Simulated tasks performed at 20-24°C; Simulated tasks performed at 30-34°C

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.

Simulated tasks performed at 20-24°C; Simulated tasks performed at 30-34°C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• European Union: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 30668567 BACKGROUND

Study Officials

• Kurt Zatloukal

  Med Uni Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Zatloukal, Dr. med.

CONTACT

+436641533264; kurt.zatloukal@medunigraz.at

Julia Kircher

CONTACT

julia.kircher@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. of Pathology

Model Details: 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).

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 24, 2026
• Study Start: July 17, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)