Personal Protective EquipmentPPE-TestNCT03004690
Testing of Personal Protective Equipment (PPE)
A study testing PPE Suit A and PPE Suit B in people with Personal Protective Equipment and Heat Stress, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Protective Equipment, Heat Stress
- What is being tested?
- PPE Suit A and PPE Suit B
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustria
- Study dates
- May 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, good physical and mental resiliance
Who cannot join
- pregnancy, latex and PVC allergy, claustrophobia, hypotension, vein thrombosis, COPD, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Limiting Factors for Wearing Personal Protective Equipment (PPE) in a Health Care Environment Evaluated in a Randomised Study: Source of Errors?
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.
Read the detailed description
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 (www.randomizer.at) and 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.
Study participants Recruiting was based on voluntary registration in response to a public announcement. The study was subjected to the local ethical committee review (No. 23-321 ex 10/11) and all persons gave written informed consent according to the Helsinki Declaration. Key lifestyle and medical parameters were documented for every subject. Exclusion criteria were pregnancy, latex and polyvinyl chloride allergy, claustrophobia, hypotension, history of vein thrombosis, chronic obstructive pulmonary disease, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases. Ten male and nine female volunteers were recruited, aged between 21 and 38 years with body-mass-indices from 17.2 to 32.5.
PPE suits Suit A: TychemR F overall whole-body (DuPont de Nemours and Company, 3M, Austria) suit including socks with a reusable light hood VersafloTM S-655 (3M, Austria) and an external 3M JupiterTM Powered Air Turbo Unit (3M Austria) providing head-only positive pressure.
Suit B: 3MTM JS-series Typ 3 Chemical and Respiratory Protective Suit (CRPS, 3M, Austria) with integrated respirator 3M Jupiter JP-ER-03 Powered Air Purifying Turbo (3M, Austria) fixed as a rucksack generating whole-suit positive pressure.
With both suits, Sempercare surgical gloves (Sempermed, powder-free 150; Semperit, Austria) as the first layer, Ansell Sol-Vex gloves 37-900 (Ansell, Medical GBU, VWR, Austria) as a second layer and white rubber boots were worn. Gloves and boots were sealed to the suit using adhesive tape. Tests I and II were performed in a mock-up glove box providing a third layer of latex gloves.
Tests Four tests were repeatedly performed as well as an additional questionnaire on comfort and general condition before the tests started and after every four-test-series. Test I comprised correct assembly and position of coloured and numbered 2 mL tubes and screwcaps in a storage device to test fine motor skills, concentration and error rate. Test II checked the same skills in a different approach by pipetting different volumes of coloured water into a 96-well microliter plate according to a given pattern. Test III "d2 Test of Attention" is a timed test of selective attention and a standardized refinement of a visual cancellation. In response to the discrimination of similar visual stimuli, the test measures processing speed, rule compliance, and quality of performance, allowing estimation of individual attention and concentration performance. Test IV investigated reaction time, mobility, speed and physical exercise by tapping touch sensors directed by signs on a screen (tapping test by talent-systems sportconsulting Gmbh, www.werthner.at). All subjects performed the tests after randomisation (www.randomizer.at) of the starting exercise. For example, subject one started with test I while subject two started with test II at the same time. After ten minutes testing time and a five minute break, subject one carried on with test II and subject two with test I. After a five minute break, subject one started with test III while subject two performed test IV over a 10 minute period. Again after five minutes break, subject one continued with test IV and subject two with test III. Subjects documented their individual comfort and general condition in a structured questionnaire before the tests started and after every series of tests. All four tests were repeated 6 times at 22°C (6 hours total working time) on the first test day and four times at 28°C (4 hours total working time) on the second test day. Limiting factors for working conditions were ranked after every series from 1 to 10 on the questionnaire whereby ranking 10 was a reason for terminating the study. Heart rate (HR) was measured with a wireless heart rate monitor placed below the sternum directly on the skin (Garmin Forerunner 305) before and after the test series (data used for statistical analysis) and additionally recorded during the test series. Body temperature and body weight were measured as well as weight of the respective PPE for calculating dehydration and evaluation of heat stress.
- Conditions
- Personal Protective Equipment, Heat Stress
- Being tested
- PPE Suit A, PPE Suit B
- Keywords
- biosafety, outbreaks, clinic, personal protective equipment, ergonomics, error rates
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPE Suit ADevice
Also called Suit A - Tychem F + - 3MTM Mehrwegleichthaube S-655
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.
PPE Suit BDevice
Also called Suit B -- 3MTM JS-Serie Typ 3 Respiratory Protective Suit
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.
| Study group | Role | What they receive |
|---|---|---|
| Performance temperature 22°C | Experimental | Participants wearing PPE suit A or PPE suit B perform tests I -IV at 22°C. Receives: 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. Receives: Device: PPE Suit A; Device: PPE Suit B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 2 months
Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.
Measured: up to 2 months
Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.
Measured: 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.
Measured: upt o 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Personal Protective EquipmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Zatloukal, Prof., Principal investigator, kurt.zatloukal@medunigraz.at
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004690
- Sponsor's protocol ID
- 23-321
- Acronym
- PPE-Test
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30668567
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limiting Factors for Wearing Personal Protective Equipment (PPE) in a Health Care Environment Evaluated in a Randomised Study: Source of Errors?
- ClinicalTrials.gov ID
- NCT03004690
- Acronym / sponsor ID
- PPE-Test / 23-321
- Conditions
- Personal Protective Equipment, Heat Stress
- Keywords
- biosafety, outbreaks, clinic, personal protective equipment, ergonomics, error rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (www.randomizer.at) and 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.
Study participants Recruiting was based on voluntary registration in response to a public announcement. The study was subjected to the local ethical committee review (No. 23-321 ex 10/11) and all persons gave written informed consent according to the Helsinki Declaration. Key lifestyle and medical parameters were documented for every subject. Exclusion criteria were pregnancy, latex and polyvinyl chloride allergy, claustrophobia, hypotension, history of vein thrombosis, chronic obstructive pulmonary disease, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases. Ten male and nine female volunteers were recruited, aged between 21 and 38 years with body-mass-indices from 17.2 to 32.5.
PPE suits Suit A: TychemR F overall whole-body (DuPont de Nemours and Company, 3M, Austria) suit including socks with a reusable light hood VersafloTM S-655 (3M, Austria) and an external 3M JupiterTM Powered Air Turbo Unit (3M Austria) providing head-only positive pressure.
Suit B: 3MTM JS-series Typ 3 Chemical and Respiratory Protective Suit (CRPS, 3M, Austria) with integrated respirator 3M Jupiter JP-ER-03 Powered Air Purifying Turbo (3M, Austria) fixed as a rucksack generating whole-suit positive pressure.
With both suits, Sempercare surgical gloves (Sempermed, powder-free 150; Semperit, Austria) as the first layer, Ansell Sol-Vex gloves 37-900 (Ansell, Medical GBU, VWR, Austria) as a second layer and white rubber boots were worn. Gloves and boots were sealed to the suit using adhesive tape. Tests I and II were performed in a mock-up glove box providing a third layer of latex gloves.
Tests Four tests were repeatedly performed as well as an additional questionnaire on comfort and general condition before the tests started and after every four-test-series. Test I comprised correct assembly and position of coloured and numbered 2 mL tubes and screwcaps in a storage device to test fine motor skills, concentration and error rate. Test II checked the same skills in a different approach by pipetting different volumes of coloured water into a 96-well microliter plate according to a given pattern. Test III "d2 Test of Attention" is a timed test of selective attention and a standardized refinement of a visual cancellation. In response to the discrimination of similar visual stimuli, the test measures processing speed, rule compliance, and quality of performance, allowing estimation of individual attention and concentration performance. Test IV investigated reaction time, mobility, speed and physical exercise by tapping touch sensors directed by signs on a screen (tapping test by talent-systems sportconsulting Gmbh, www.werthner.at). All subjects performed the tests after randomisation (www.randomizer.at) of the starting exercise. For example, subject one started with test I while subject two started with test II at the same time. After ten minutes testing time and a five minute break, subject one carried on with test II and subject two with test I. After a five minute break, subject one started with test III while subject two performed test IV over a 10 minute period. Again after five minutes break, subject one continued with test IV and subject two with test III. Subjects documented their individual comfort and general condition in a structured questionnaire before the tests started and after every series of tests. All four tests were repeated 6 times at 22°C (6 hours total working time) on the first test day and four times at 28°C (4 hours total working time) on the second test day. Limiting factors for working conditions were ranked after every series from 1 to 10 on the questionnaire whereby ranking 10 was a reason for terminating the study. Heart rate (HR) was measured with a wireless heart rate monitor placed below the sternum directly on the skin (Garmin Forerunner 305) before and after the test series (data used for statistical analysis) and additionally recorded during the test series. Body temperature and body weight were measured as well as weight of the respective PPE for calculating dehydration and evaluation of heat stress.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance temperature 22°C | Experimental | Device: PPE Suit A, Device: PPE Suit BParticipants wearing PPE suit A or PPE suit B perform tests I -IV at 22°C. |
| Performance temperature 28°C | Experimental | Device: PPE Suit A, Device: PPE Suit BParticipants wearing PPE suit A or PPE suit B perform tests I -IV at 28°C. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy, good physical and mental resiliance
Key exclusion criteria (1 listed)
- pregnancy, latex and PVC allergy, claustrophobia, hypotension, vein thrombosis, COPD, epilepsy, cardiovascular and pulmonary diseases, and infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPE Suit AAlso: Suit A - Tychem F + - 3MTM Mehrwegleichthaube S-655In 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. | Device | Performance temperature 22°C, Performance temperature 28°C |
| PPE Suit BAlso: Suit B -- 3MTM JS-Serie Typ 3 Respiratory Protective SuitSuit 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. | Device | Performance temperature 22°C, Performance temperature 28°C |
Primary outcome
Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants
Time frame: up to 2 months
Measurement of concentration (d2 Test) at 22°C and 28°C in each suit with 19 participants.
Time frame: up to 2 months
This test will be analysed by descriptive analysis.
Measurement of error rates at 22°C and 28°C in each suit with 19 participants
Time frame: up to 2 months
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.
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.
Time frame: up to 2 months
Questionnaire data are recorded 7 times at 22°C and 5 times at 28°C and analysed with descriptive statistics.
Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.
Time frame: up to 2 months
Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.
Time frame: up to 2 months
Measurement of reaction time at 22°C and 28°C in each suit with 19 participants.
Time frame: upt o 2 months
This test will be analysed by descriptive analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 30668567Loibner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Zatloukal, Prof. principal investigator
kurt.zatloukal@medunigraz.at
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPE Suit A and PPE Suit B in people with Personal Protective Equipment and Heat Stress, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants (time frame: up to 2 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.