Testing of Personal Protective Equipment (PPE)

NCT03004690 | Completed

• 1 other identifier: 23-321
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Pandemics and re-emerging diseases put pressure on the health care system to prepare for patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for health care workers. We generated quantifiable data on ergonomics of PPE applicable in a health care setting by defining error rates and physically limiting factors due to PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four different tests (two laboratory tutorials, a timed test of selective attention and a test investigating reaction time, mobility, speed and physical exercise) during 6 working hours at 22°C on one day and 4 working hours at 28°C on another day. Error rates and physical parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related parameters were assessed hourly using questionnaires. Depending on the PPE system the most restrictive factors were: reduced dexterity due to multiple glove layers, impaired visibility by flexible face shields and back pain related to the respirator of the fully ventilated suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of 28°C but not 22°C.

Conditions

Personal Protective Equipment; Heat Stress

Keywords

biosafety; outbreaks; clinic; personal protective equipment; ergonomics; error rates

Outcome Measures

Primary Outcomes (7)

• Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants

  up to 2 months

• Measurement of concentration (d2 Test) at 22°C and 28°C in each suit with 19 participants.

  This test will be analysed by descriptive analysis.

  up to 2 months

• Measurement of error rates at 22°C and 28°C in each suit with 19 participants

  For both temperatures repeated measurements and analysis of variances (rmANOVA) to assess effects of working time as a within subject factor and suit (A, B) as a between subject factor on the amount of processed tubes and the amount of wrongly screwed or arranged tubes are performed.

  up to 2 months

• Measurement of individual perception and wellbeing during all test series by individual questionnaires at 22°C and 28°C in each suit with 19 participants.

  Questionnaire data are recorded 7 times at 22°C and 5 times at 28°C and analysed with descriptive statistics.

  up to 2 months

• Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.

  up to 2 months

• Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.

  up to 2 months

• Measurement of reaction time at 22°C and 28°C in each suit with 19 participants.

  This test will be analysed by descriptive analysis.

  upt o 2 months

Study Arms (2)

Performance temperature 22°C

EXPERIMENTAL

Participants wearing PPE suit A or PPE suit B perform tests I -IV at 22°C.

Device: PPE Suit A; Device: PPE Suit B

Performance temperature 28°C

EXPERIMENTAL

Participants wearing PPE suit A or PPE suit B perform tests I -IV at 28°C.

Device: PPE Suit A; Device: PPE Suit B

Interventions

PPE Suit A DEVICE

In this randomized study following good clinical practice guidelines nineteen study volunteers were recruited to wear one of two different types of randomly allocated PPE suits. Suit A has to be used by randomly selected participants to perform four different tests six times at 22°C on one day and four times at 28°C on another day in the local core facility clinical research center.

Also known as: Suit A - Tychem F + - 3MTM Mehrwegleichthaube S-655

Performance temperature 22°C; Performance temperature 28°C

PPE Suit B DEVICE

Suit B has to be used by randomly selected participants to perform four different tests six times at 22°C on one day and four times at 28°C on another day in the local core facility clinical research center.

Also known as: Suit B -- 3MTM JS-Serie Typ 3 Respiratory Protective Suit

Performance temperature 22°C; Performance temperature 28°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:

• healthy, good physical and mental resiliance

You may not qualify if:

• pregnancy, latex and PVC allergy, claustrophobia, hypotension, vein thrombosis, COPD, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, 8036, Austria

Location

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 DERIVED

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kurt Zatloukal, Prof.

  kurt.zatloukal@medunigraz.at

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 29, 2016
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)