<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004690</url>
  </required_header>
  <id_info>
    <org_study_id>23-321</org_study_id>
    <nct_id>NCT03004690</nct_id>
  </id_info>
  <brief_title>Testing of Personal Protective Equipment (PPE)</brief_title>
  <acronym>PPE-Test</acronym>
  <official_title>Limiting Factors for Wearing Personal Protective Equipment (PPE) in a Health Care Environment Evaluated in a Randomised Study: Source of Errors?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pandemics and re-emerging diseases put pressure on the health care system to prepare for&#xD;
      patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for&#xD;
      health care workers. We generated quantifiable data on ergonomics of PPE applicable in a&#xD;
      health care setting by defining error rates and physically limiting factors due to&#xD;
      PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full&#xD;
      body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four&#xD;
      different tests (two laboratory tutorials, a timed test of selective attention and a test&#xD;
      investigating reaction time, mobility, speed and physical exercise) during 6 working hours at&#xD;
      22°C on one day and 4 working hours at 28°C on another day. Error rates and physical&#xD;
      parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related&#xD;
      parameters were assessed hourly using questionnaires. Depending on the PPE system the most&#xD;
      restrictive factors were: reduced dexterity due to multiple glove layers, impaired visibility&#xD;
      by flexible face shields and back pain related to the respirator of the fully ventilated&#xD;
      suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of&#xD;
      28°C but not 22°C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized study following good clinical practice guidelines nineteen study&#xD;
      volunteers were recruited to wear one of two different types of randomly allocated PPE suits&#xD;
      (www.randomizer.at) and to perform four different tests six times at 22°C on one day and four&#xD;
      times at 28°C on another day in the local core facility clinical research center.&#xD;
&#xD;
      Study participants Recruiting was based on voluntary registration in response to a public&#xD;
      announcement. The study was subjected to the local ethical committee review (No. 23-321 ex&#xD;
      10/11) and all persons gave written informed consent according to the Helsinki Declaration.&#xD;
      Key lifestyle and medical parameters were documented for every subject. Exclusion criteria&#xD;
      were pregnancy, latex and polyvinyl chloride allergy, claustrophobia, hypotension, history of&#xD;
      vein thrombosis, chronic obstructive pulmonary disease, epilepsy, cardiovascular and&#xD;
      pulmonary diseases, and infectious diseases. Ten male and nine female volunteers were&#xD;
      recruited, aged between 21 and 38 years with body-mass-indices from 17.2 to 32.5.&#xD;
&#xD;
      PPE suits Suit A: TychemR F overall whole-body (DuPont de Nemours and Company, 3M, Austria)&#xD;
      suit including socks with a reusable light hood VersafloTM S-655 (3M, Austria) and an&#xD;
      external 3M JupiterTM Powered Air Turbo Unit (3M Austria) providing head-only positive&#xD;
      pressure.&#xD;
&#xD;
      Suit B: 3MTM JS-series Typ 3 Chemical and Respiratory Protective Suit (CRPS, 3M, Austria)&#xD;
      with integrated respirator 3M Jupiter JP-ER-03 Powered Air Purifying Turbo (3M, Austria)&#xD;
      fixed as a rucksack generating whole-suit positive pressure.&#xD;
&#xD;
      With both suits, Sempercare surgical gloves (Sempermed, powder-free 150; Semperit, Austria)&#xD;
      as the first layer, Ansell Sol-Vex gloves 37-900 (Ansell, Medical GBU, VWR, Austria) as a&#xD;
      second layer and white rubber boots were worn. Gloves and boots were sealed to the suit using&#xD;
      adhesive tape. Tests I and II were performed in a mock-up glove box providing a third layer&#xD;
      of latex gloves.&#xD;
&#xD;
      Tests Four tests were repeatedly performed as well as an additional questionnaire on comfort&#xD;
      and general condition before the tests started and after every four-test-series. Test I&#xD;
      comprised correct assembly and position of coloured and numbered 2 mL tubes and screwcaps in&#xD;
      a storage device to test fine motor skills, concentration and error rate. Test II checked the&#xD;
      same skills in a different approach by pipetting different volumes of coloured water into a&#xD;
      96-well microliter plate according to a given pattern. Test III &quot;d2 Test of Attention&quot; is a&#xD;
      timed test of selective attention and a standardized refinement of a visual cancellation. In&#xD;
      response to the discrimination of similar visual stimuli, the test measures processing speed,&#xD;
      rule compliance, and quality of performance, allowing estimation of individual attention and&#xD;
      concentration performance. Test IV investigated reaction time, mobility, speed and physical&#xD;
      exercise by tapping touch sensors directed by signs on a screen (tapping test by&#xD;
      talent-systems sportconsulting Gmbh, www.werthner.at). All subjects performed the tests after&#xD;
      randomisation (www.randomizer.at) of the starting exercise. For example, subject one started&#xD;
      with test I while subject two started with test II at the same time. After ten minutes&#xD;
      testing time and a five minute break, subject one carried on with test II and subject two&#xD;
      with test I. After a five minute break, subject one started with test III while subject two&#xD;
      performed test IV over a 10 minute period. Again after five minutes break, subject one&#xD;
      continued with test IV and subject two with test III. Subjects documented their individual&#xD;
      comfort and general condition in a structured questionnaire before the tests started and&#xD;
      after every series of tests. All four tests were repeated 6 times at 22°C (6 hours total&#xD;
      working time) on the first test day and four times at 28°C (4 hours total working time) on&#xD;
      the second test day. Limiting factors for working conditions were ranked after every series&#xD;
      from 1 to 10 on the questionnaire whereby ranking 10 was a reason for terminating the study.&#xD;
      Heart rate (HR) was measured with a wireless heart rate monitor placed below the sternum&#xD;
      directly on the skin (Garmin Forerunner 305) before and after the test series (data used for&#xD;
      statistical analysis) and additionally recorded during the test series. Body temperature and&#xD;
      body weight were measured as well as weight of the respective PPE for calculating dehydration&#xD;
      and evaluation of heat stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants</measure>
    <time_frame>up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of concentration (d2 Test) at 22°C and 28°C in each suit with 19 participants.</measure>
    <time_frame>up to 2 months</time_frame>
    <description>This test will be analysed by descriptive analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of error rates at 22°C and 28°C in each suit with 19 participants</measure>
    <time_frame>up to 2 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>up to 2 months</time_frame>
    <description>Questionnaire data are recorded 7 times at 22°C and 5 times at 28°C and analysed with descriptive statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.</measure>
    <time_frame>up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.</measure>
    <time_frame>up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of reaction time at 22°C and 28°C in each suit with 19 participants.</measure>
    <time_frame>upt o 2 months</time_frame>
    <description>This test will be analysed by descriptive analysis.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Personal Protective Equipment</condition>
  <condition>Heat Stress</condition>
  <arm_group>
    <arm_group_label>Performance temperature 22°C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants wearing PPE suit A or PPE suit B perform tests I -IV at 22°C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Performance temperature 28°C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants wearing PPE suit A or PPE suit B perform tests I -IV at 28°C.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PPE Suit A</intervention_name>
    <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. 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.</description>
    <arm_group_label>Performance temperature 22°C</arm_group_label>
    <arm_group_label>Performance temperature 28°C</arm_group_label>
    <other_name>Suit A - Tychem F + - 3MTM Mehrwegleichthaube S-655</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PPE Suit B</intervention_name>
    <description>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.</description>
    <arm_group_label>Performance temperature 22°C</arm_group_label>
    <arm_group_label>Performance temperature 28°C</arm_group_label>
    <other_name>Suit B -- 3MTM JS-Serie Typ 3 Respiratory Protective Suit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy, good physical and mental resiliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, latex and PVC allergy, claustrophobia, hypotension, vein thrombosis, COPD,&#xD;
             epilepsy, cardiovascular and pulmonary diseases, and infectious diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Zatloukal, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>kurt.zatloukal@medunigraz.at</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biosafety</keyword>
  <keyword>outbreaks</keyword>
  <keyword>clinic</keyword>
  <keyword>personal protective equipment</keyword>
  <keyword>ergonomics</keyword>
  <keyword>error rates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heat Stress Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004690
org study id: 23-321
nct id: NCT03004690
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Physical measurements: Heart rate at 22°C and 28°C in each suit with 19 participants
time frame: up to 2 months
measure: Measurement of concentration (d2 Test) at 22°C and 28°C in each suit with 19 participants.
time frame: up to 2 months
description: This test will be analysed by descriptive analysis.
measure: Measurement of error rates at 22°C and 28°C in each suit with 19 participants
time frame: up to 2 months
description: 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.
measure: 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
description: Questionnaire data are recorded 7 times at 22°C and 5 times at 28°C and analysed with descriptive statistics.
measure: Physical measurements: Fluid loss at 22°C and 28°C in each suit with 19 participants.
time frame: up to 2 months
measure: Physical measurements: Body temperature at 22°C and 28°C in each suit with 19 participants.
time frame: up to 2 months
measure: Measurement of reaction time at 22°C and 28°C in each suit with 19 participants.
time frame: upt o 2 months
description: This test will be analysed by descriptive analysis.
arm group label: Performance temperature 22°C
arm group type: Experimental
description: Participants wearing PPE suit A or PPE suit B perform tests I -IV at 22°C.
arm group label: Performance temperature 28°C
arm group type: Experimental
description: Participants wearing PPE suit A or PPE suit B perform tests I -IV at 28°C.
intervention type: Device
intervention name: PPE Suit A
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. 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.
arm group label: Performance temperature 22°C
arm group label: Performance temperature 28°C
other name: Suit A - Tychem F + - 3MTM Mehrwegleichthaube S-655
intervention type: Device
intervention name: PPE Suit B
description: 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.
arm group label: Performance temperature 22°C
arm group label: Performance temperature 28°C
other name: Suit B -- 3MTM JS-Serie Typ 3 Respiratory Protective Suit
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kurt Zatloukal, Prof.
role: Principal Investigator
affiliation: kurt.zatloukal@medunigraz.at
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Heat Stress Disorders
sharing ipd: No