Testing of Personal Protective Equipment (PPE) for First Responders

Overview

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.

Interventions

• Other 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 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.

Primary outcome measures

• Body weight [Time frame: 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)]
• Blood pressure [Time frame: 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)]
• Body temperature [Time frame: Baseline, during the test, and after completion of test (max 6 hours)]
• Humidity [Time frame: For the duration of the test (max 6 hours)]
• Mean reaction time [Time frame: 10 minutes]
• Semi-quantitative questionnaire on subjective wellbeing [Time frame: 5 min]
• Resilience scale questionnaire RS-13 [Time frame: 5 min]
• Error rate [Time frame: Max 20 min]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Other

Study locations

Austria · 1 center

• Medical University of Graz — Graz

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. PMID 30668567

Identifiers

NCT: NCT07726537 · 1168_2026 · 101168322 - EMBRACE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗