Testing of Personal Protective Equipment (PPE) for First Responders

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Body weight [Срок оценки: Baseline and at completion/termination (max. 6 hours after start)]
• Heart rate [Срок оценки: Baseline, continuously during the test, and after completion of test (max 6 hours)]
• Blood pressure [Срок оценки: Baseline and after completion of test (max 6 hours)]
• Weight of Category III PPE suit [Срок оценки: Baseline and after completion of test (max 6 hours)]
• Body temperature [Срок оценки: Baseline, during the test, and after completion of test (max 6 hours)]
• Humidity [Срок оценки: For the duration of the test (max 6 hours)]
• Mean reaction time [Срок оценки: 10 minutes]
• Semi-quantitative questionnaire on subjective wellbeing [Срок оценки: 5 min]
• Resilience scale questionnaire RS-13 [Срок оценки: 5 min]
• Error rate [Срок оценки: Max 20 min]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Австрия · 1 центр

• Medical University of Graz — Graz

Публикации

• 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

Идентификаторы

NCT: NCT07726537 · 1168_2026 · 101168322 - EMBRACE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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