<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/NCT04411056</url>
  </required_header>
  <id_info>
    <org_study_id>2004-38</org_study_id>
    <nct_id>NCT04411056</nct_id>
  </id_info>
  <brief_title>A Study Comparing Time to Intubate With and Without a Barrier Box</brief_title>
  <official_title>Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      This study is for patients who will be having surgery and will have a breathing tube placed&#xD;
      during intubation. The purpose of the research is to study the time it takes to use a barrier&#xD;
      box for placement of a breathing tube. A barrier box is a clear box that sits over the head&#xD;
      and shoulders of a patient as a breathing tube is placed. The box is used to protect the&#xD;
      healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will&#xD;
      not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms.&#xD;
      The researchers want to learn how long it takes to use the barrier box before it is used&#xD;
      routinely in COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will have two groups of 39 patients in each group. Some patients will have a&#xD;
      barrier box and some patients will not have a barrier box. Patients will be randomly assigned&#xD;
      to the barrier box or no barrier box group. The study will measure the time it takes to place&#xD;
      the breathing tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">May 19, 2020</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>
    <intervention_model_description>Participants assigned to barrier box or no barrier box</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to intubate</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Number of seconds to intubate (from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attempts at intubation</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Number of attempts at intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for bag mask ventilation</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Need for bag mask ventilation (yes or no) during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest oxygen saturation during induction and intubation</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Lowest peripheral capillary oxygen saturation during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>Barrier box</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have a barrier box placed during intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Barrier box</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will have routine intubation with no barrier box</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Barrier box</intervention_name>
    <description>Placement of barrier box ( a plastic box for shielding)</description>
    <arm_group_label>Barrier box</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients presenting for surgery needing general anesthesia with endotracheal&#xD;
             intubation&#xD;
&#xD;
          -  pre-operatively tested negative for SARS- CoV-2 virus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to consent or cooperate,&#xD;
&#xD;
          -  children&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  patients with severe cardiopulmonary compromise&#xD;
&#xD;
          -  American Society Anesthesiologists' (ASA) physical status 4 and 5&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;35&#xD;
&#xD;
          -  known or anticipated difficult airway&#xD;
&#xD;
          -  patients with positive COVID status or unknown COVID status&#xD;
&#xD;
          -  patients who reported claustrophobia in the pre-operative area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Praneeth Madabhushi, MD, MHCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Guthrie Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04411056
org study id: 2004-38
nct id: NCT04411056
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is for patients who will be having surgery and will have a breathing tube placed
      during intubation. The purpose of the research is to study the time it takes to use a barrier
      box for placement of a breathing tube. A barrier box is a clear box that sits over the head
      and shoulders of a patient as a breathing tube is placed. The box is used to protect the
      healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will
      not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms.
      The researchers want to learn how long it takes to use the barrier box before it is used
      routinely in COVID-19 patients.
The study will have two groups of 39 patients in each group. Some patients will have a
      barrier box and some patients will not have a barrier box. Patients will be randomly assigned
      to the barrier box or no barrier box group. The study will measure the time it takes to place
      the breathing tube.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants assigned to barrier box or no barrier box
primary purpose: Other
masking: None (Open Label)
measure: Time to intubate
time frame: up to 10 minutes
description: Number of seconds to intubate (from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.
measure: Attempts at intubation
time frame: up to 10 minutes
description: Number of attempts at intubation
measure: Need for bag mask ventilation
time frame: up to 10 minutes
description: Need for bag mask ventilation (yes or no) during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
measure: Lowest oxygen saturation during induction and intubation
time frame: up to 10 minutes
description: Lowest peripheral capillary oxygen saturation during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
arm group label: Barrier box
arm group type: Experimental
description: Participants will have a barrier box placed during intubation
arm group label: No Barrier box
arm group type: No Intervention
description: Participants will have routine intubation with no barrier box
intervention type: Other
intervention name: Barrier box
description: Placement of barrier box ( a plastic box for shielding)
arm group label: Barrier box
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Praneeth Madabhushi, MD, MHCA
role: Principal Investigator
affiliation: The Guthrie Clinic
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No