<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/NCT04449042</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00035427</org_study_id>
    <nct_id>NCT04449042</nct_id>
  </id_info>
  <brief_title>The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry</brief_title>
  <official_title>Pediatric Airway Management Complications During the COVID-19 Pandemic. An International, Multicenter, Observational Registry: The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istituto Giannina Gaslini</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Perth Children's Hospital of Western Austrailia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The COVID-19 pandemic has disrupted anesthesia care all over the world. There remains very&#xD;
      little data on current practice patterns and patient outcomes, particularly in anesthetized&#xD;
      children. This is a prospective observational, multi-center study to investigate airway&#xD;
      management related outcomes in children undergoing anesthesia during this pandemic. The&#xD;
      investigators will compare the incidence of complications (particularly hypoxemia) in&#xD;
      patients with COVID-19 to those who are COVID-19 negative during airway management.&#xD;
&#xD;
      PAWS COVID-19 Registry https://is.gd/PEDICOVID19&#xD;
&#xD;
      Registration link https://is.gd/researchrequest&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>airway complications</measure>
    <time_frame>throughout duration of anesthetic</time_frame>
    <description>incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>airway device</measure>
    <time_frame>throughout duration of anesthetic</time_frame>
    <description>type of device inserted for airway control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PPE</measure>
    <time_frame>throughout duration of anesthetic</time_frame>
    <description>the type of PPE used by anesthetists and assistants during airway management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First pass success</measure>
    <time_frame>during induction and intubation</time_frame>
    <description>compare the first attempt success rate of tracheal intubation in patients with the disease to those without the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>induction techniques</measure>
    <time_frame>during induction of anesthesia</time_frame>
    <description>variability in practice for induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>failed intubation</measure>
    <time_frame>during induction of anesthesia</time_frame>
    <description>determine the Incidence of failed intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication risk factors</measure>
    <time_frame>during anesthetic management</time_frame>
    <description>determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">14835</enrollment>
  <condition>Airway Management</condition>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>COVID19 positive</arm_group_label>
    <description>a recently performed test which is positive for coronavirus infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 negative</arm_group_label>
    <description>a recently performed test which is negative for coronavirus infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 presumed positive</arm_group_label>
    <description>patients who do not have testing or who have negative testing but whose symptoms, history, physical exam, laboratory and imaging findings are consistent with infection with COVID19 and are treated as positive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 presumed negative</arm_group_label>
    <description>patients who do not have testing, but based on symptoms, history, physical exam, laboratory and imaging findings are deemed to be low risk for COVID19 infection and are treated as negative</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>airway management during sedation or general anesthesia</intervention_name>
    <description>airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure</description>
    <arm_group_label>COVID19 negative</arm_group_label>
    <arm_group_label>COVID19 positive</arm_group_label>
    <arm_group_label>COVID19 presumed negative</arm_group_label>
    <arm_group_label>COVID19 presumed positive</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all children (from birth to 18yrs) receiving sedation or&#xD;
        general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure.&#xD;
        Each institution will collect de-identified data on all children under anesthetic care for&#xD;
        a two week period. In addition, data collection for all children who are positive or&#xD;
        presumed positive for COVID19 receiving anesthetic care will be collected outside of the&#xD;
        two week period until study completion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing an inpatient or outpatient procedure under general anesthesia with or&#xD;
             without regional analgesia&#xD;
&#xD;
          -  Undergoing a diagnostic procedure under sedation or general anesthesia&#xD;
&#xD;
          -  Undergoing an urgent or emergent procedure performed during and outside of the regular&#xD;
             operating room schedule hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  Children admitted to the operating room already intubated&#xD;
&#xD;
          -  Children who require tracheal intubation for life-threatening conditions in the&#xD;
             emergency department, intensive care, or hospital ward.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John E Fiadjoe, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melissa Brooks Peterson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hopsital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Mary Lyn Stein</investigator_full_name>
    <investigator_title>Assistant in Perioperative Anesthesia</investigator_title>
  </responsible_party>
  <keyword>COVID19 pediatric</keyword>
  <keyword>intubation</keyword>
  <keyword>anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04449042
org study id: IRB-P00035427
nct id: NCT04449042
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic has disrupted anesthesia care all over the world. There remains very
      little data on current practice patterns and patient outcomes, particularly in anesthetized
      children. This is a prospective observational, multi-center study to investigate airway
      management related outcomes in children undergoing anesthesia during this pandemic. The
      investigators will compare the incidence of complications (particularly hypoxemia) in
      patients with COVID-19 to those who are COVID-19 negative during airway management.

      PAWS COVID-19 Registry https://is.gd/PEDICOVID19

      Registration link https://is.gd/researchrequest
observational model: Cohort
time perspective: Prospective
measure: airway complications
time frame: throughout duration of anesthetic
description: incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management
measure: airway device
time frame: throughout duration of anesthetic
description: type of device inserted for airway control
measure: PPE
time frame: throughout duration of anesthetic
description: the type of PPE used by anesthetists and assistants during airway management
measure: First pass success
time frame: during induction and intubation
description: compare the first attempt success rate of tracheal intubation in patients with the disease to those without the disease
measure: induction techniques
time frame: during induction of anesthesia
description: variability in practice for induction of anesthesia
measure: failed intubation
time frame: during induction of anesthesia
description: determine the Incidence of failed intubation
measure: complication risk factors
time frame: during anesthetic management
description: determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)
arm group label: COVID19 positive
description: a recently performed test which is positive for coronavirus infection
arm group label: COVID19 negative
description: a recently performed test which is negative for coronavirus infection
arm group label: COVID19 presumed positive
description: patients who do not have testing or who have negative testing but whose symptoms, history, physical exam, laboratory and imaging findings are consistent with infection with COVID19 and are treated as positive
arm group label: COVID19 presumed negative
description: patients who do not have testing, but based on symptoms, history, physical exam, laboratory and imaging findings are deemed to be low risk for COVID19 infection and are treated as negative
intervention type: Procedure
intervention name: airway management during sedation or general anesthesia
description: airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure
arm group label: COVID19 negative
arm group label: COVID19 positive
arm group label: COVID19 presumed negative
arm group label: COVID19 presumed positive
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: John E Fiadjoe, MD
role: Study Chair
affiliation: Children's Hospital of Philadelphia
last name: Melissa Brooks Peterson, MD
role: Principal Investigator
affiliation: Colorado Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Mary Lyn Stein
investigator title: Assistant in Perioperative Anesthesia
mesh term: COVID-19
mesh term: Anesthetics