<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/NCT04412226</url>
  </required_header>
  <id_info>
    <org_study_id>2020/56</org_study_id>
    <nct_id>NCT04412226</nct_id>
  </id_info>
  <brief_title>Effect of Using Barrier Devices for Intubation in COVID-19 Patients</brief_title>
  <official_title>Effect of Using Barrier Devices for Intubation in COVID-19 Patients: Randomized, Prospective, Manikin Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derince Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derince Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the impact of using the aerosol box and transparent sheet&#xD;
      as an adjunct to conventional personal protective equipment on endotracheal intubation of&#xD;
      COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during&#xD;
      the mentioned simulated scenarios.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, prospective, manikin simulation study. Emergency medicine specialists&#xD;
      will be participated in the study. Participants will be randomly assigned into 6 groups with&#xD;
      a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating&#xD;
      online random numbers. 13 participants will be recruited to the study.&#xD;
&#xD;
      Operators who will intubate the manikin will use following methods: (1) conventional personal&#xD;
      protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box&#xD;
      as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet&#xD;
      as an adjunct to PPE with placing the manikin in the supine position. (4) conventional&#xD;
      personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the&#xD;
      bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the&#xD;
      30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE&#xD;
      with placing the manikin in the 30 degree the head of the bed elevated position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>First pass success</measure>
    <time_frame>2 minutes</time_frame>
    <description>Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to endotracheal intubation</measure>
    <time_frame>2 minutes</time_frame>
    <description>The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty level of accessing the equipment</measure>
    <time_frame>2 minutes</time_frame>
    <description>Grading the difficulty of accessing the equipment on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty level of inserting the endotracheal tube into the glottis</measure>
    <time_frame>2 minutes</time_frame>
    <description>Grading the difficulty of inserting the endotracheal tube into the glottis on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clarity of the view of the patient's face</measure>
    <time_frame>2 minutes</time_frame>
    <description>Grading the clarity of the view of the patient's face on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.</description>
  </secondary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>aerosol box</intervention_name>
    <description>The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transparent sheet</intervention_name>
    <description>The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes emergency medicine specialists who wants to participate to&#xD;
        the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who want to participate the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who do not want to participate the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kocaeli Derince Training and Research Hospital</name>
      <address>
        <city>Kocaeli</city>
        <state>Izmit</state>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://sites.google.com/view/aerosolbox/home?authuser=0</url>
    <description>Aerosol Box</description>
  </link>
  <reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </reference>
  <reference>
    <citation>Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum In: JAMA. 2021 May 25;325(20):2120.</citation>
    <PMID>32250385</PMID>
  </reference>
  <reference>
    <citation>Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.</citation>
    <PMID>22563403</PMID>
  </reference>
  <reference>
    <citation>Feldman O, Meir M, Shavit D, Idelman R, Shavit I. Exposure to a Surrogate Measure of Contamination From Simulated Patients by Emergency Department Personnel Wearing Personal Protective Equipment. JAMA. 2020 May 26;323(20):2091-2093. doi: 10.1001/jama.2020.6633.</citation>
    <PMID>32338711</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derince Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ASIM ENES ÖZBEK</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>aerosol box</keyword>
  <keyword>COVID-19</keyword>
  <keyword>intubation</keyword>
  <keyword>personal protective equipment</keyword>
  <keyword>barrier device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04412226
org study id: 2020/56
nct id: NCT04412226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the impact of using the aerosol box and transparent sheet
      as an adjunct to conventional personal protective equipment on endotracheal intubation of
      COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during
      the mentioned simulated scenarios.
This is a randomized, prospective, manikin simulation study. Emergency medicine specialists
      will be participated in the study. Participants will be randomly assigned into 6 groups with
      a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating
      online random numbers. 13 participants will be recruited to the study.

      Operators who will intubate the manikin will use following methods: (1) conventional personal
      protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box
      as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet
      as an adjunct to PPE with placing the manikin in the supine position. (4) conventional
      personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the
      bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the
      30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE
      with placing the manikin in the 30 degree the head of the bed elevated position.
observational model: Other
time perspective: Prospective
measure: First pass success
time frame: 2 minutes
description: Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study.
measure: Time to endotracheal intubation
time frame: 2 minutes
description: The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study.
measure: Difficulty level of accessing the equipment
time frame: 2 minutes
description: Grading the difficulty of accessing the equipment on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
measure: Difficulty level of inserting the endotracheal tube into the glottis
time frame: 2 minutes
description: Grading the difficulty of inserting the endotracheal tube into the glottis on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
measure: Clarity of the view of the patient's face
time frame: 2 minutes
description: Grading the clarity of the view of the patient's face on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
intervention type: Device
intervention name: aerosol box
description: The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms.
intervention type: Device
intervention name: transparent sheet
description: The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
url: http://sites.google.com/view/aerosolbox/home?authuser=0
description: Aerosol Box
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
citation: Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum In: JAMA. 2021 May 25;325(20):2120.
PMID: 32250385
citation: Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.
PMID: 22563403
citation: Feldman O, Meir M, Shavit D, Idelman R, Shavit I. Exposure to a Surrogate Measure of Contamination From Simulated Patients by Emergency Department Personnel Wearing Personal Protective Equipment. JAMA. 2020 May 26;323(20):2091-2093. doi: 10.1001/jama.2020.6633.
PMID: 32338711
responsible party type: Principal Investigator
investigator affiliation: Derince Training and Research Hospital
investigator full name: ASIM ENES ÖZBEK
investigator title: Principal Investigator
mesh term: COVID-19
sharing ipd: No