<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/NCT02224612</url>
  </required_header>
  <id_info>
    <org_study_id>R13-044</org_study_id>
    <nct_id>NCT02224612</nct_id>
  </id_info>
  <brief_title>A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks</brief_title>
  <official_title>A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medline Industries</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the fit of two pediatric face masks in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, open-label comparative observational study to be conducted&#xD;
      in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age).&#xD;
      The usage of face masks is common practice within hospitals, and masks may be evaluated&#xD;
      outside of clinical facilities as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Carbon Dioxide Levels</measure>
    <time_frame>Baseline and 2 minutes</time_frame>
    <description>ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Fit of Pediatric Face Masks.</measure>
    <time_frame>Immediate</time_frame>
    <description>Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.&#xD;
The total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in Respiration Rates</measure>
    <time_frame>Baseline and 2 minutes</time_frame>
    <description>Change from Baseline</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Children 4-5 yrs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medline Pediatric Face Mask KC Childs Face Mask&#xD;
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children 6-9 yrs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medline Pediatric Face Mask KC Childs Face Mask&#xD;
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children 10-12 yrs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medline Pediatric Face Mask KC Childs Face Mask&#xD;
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medline Pediatric Face Masks</intervention_name>
    <description>Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.</description>
    <arm_group_label>Children 10-12 yrs</arm_group_label>
    <arm_group_label>Children 4-5 yrs</arm_group_label>
    <arm_group_label>Children 6-9 yrs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KC Childs Mask</intervention_name>
    <description>KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.</description>
    <arm_group_label>Children 10-12 yrs</arm_group_label>
    <arm_group_label>Children 4-5 yrs</arm_group_label>
    <arm_group_label>Children 6-9 yrs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4 to 12 years of age&#xD;
&#xD;
          -  conscious&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  able to wear a mask&#xD;
&#xD;
          -  no previous allergic reactions to face masks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward Drower, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medline Industries Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medline Industries, Inc</name>
      <address>
        <city>Mundelein</city>
        <state>Illinois</state>
        <zip>60060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>August 29, 2017</results_first_submitted>
  <results_first_submitted_qc>April 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2019</results_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric Face Masks</keyword>
  <keyword>children</keyword>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Medline Face Mask First</title>
          <description>Medline Face Mask first, then KC Childs Mask</description>
        </group>
        <group group_id="P2">
          <title>KC Childs Mask First</title>
          <description>KC Childs Mask first, then Medline Face Mask</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Partipants</title>
          <description>All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>4-5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-9 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-12 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EtCO2</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Medline Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.7" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KC Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.8" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiration Rate</title>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Medline Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.3" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KC Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.0" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Carbon Dioxide Levels</title>
        <description>ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.</description>
        <time_frame>Baseline and 2 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medline Pediatric Face Mask</title>
            <description>All participants Medline Pediatric Face Mask</description>
          </group>
          <group group_id="O2">
            <title>KC Childs Mask</title>
            <description>All subjects KC Childs Mask</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Carbon Dioxide Levels</title>
          <description>ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="3.56"/>
                    <measurement group_id="O2" value="-0.79" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Fit of Pediatric Face Masks.</title>
        <description>Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.&#xD;
The total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.</description>
        <time_frame>Immediate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Particpants</title>
            <description>Medline Pediatric Face Mask KC Childs Face Mask</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Fit of Pediatric Face Masks.</title>
          <description>Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.&#xD;
The total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medline Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".80" spread=".79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KC Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".31" spread=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Respiration Rates</title>
        <description>Change from Baseline</description>
        <time_frame>Baseline and 2 minutes</time_frame>
        <population>Respiration Rate</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Medline Pediatric Face Mask KC Childs Face Mask</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiration Rates</title>
          <description>Change from Baseline</description>
          <population>Respiration Rate</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medline Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" spread=".41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KC Mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Medline Pediatric Face Mask</title>
          <description>Medline Face Mask</description>
        </group>
        <group group_id="E2">
          <title>KC Childs Face Mask</title>
          <description>KC Face Mask</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ed Drower</name_or_title>
      <organization>Medline Industries, Inc.</organization>
      <phone>847-643-3874</phone>
      <email>edrower@medline.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02224612
org study id: R13-044
nct id: NCT02224612
lead sponsor: 
has dmc: No
Compare the fit of two pediatric face masks in children.
This is a prospective, randomized, open-label comparative observational study to be conducted
      in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age).
      The usage of face masks is common practice within hospitals, and masks may be evaluated
      outside of clinical facilities as well.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change From Baseline in Carbon Dioxide Levels
time frame: Baseline and 2 minutes
description: ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.
measure: Physical Fit of Pediatric Face Masks.
time frame: Immediate
description: Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.
The total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.
measure: Change From Baseline in Respiration Rates
time frame: Baseline and 2 minutes
description: Change from Baseline
arm group label: Children 4-5 yrs
arm group type: Active Comparator
description: Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
arm group label: Children 6-9 yrs
arm group type: Active Comparator
description: Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
arm group label: Children 10-12 yrs
arm group type: Active Comparator
description: Medline Pediatric Face Mask KC Childs Face Mask
Comparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
intervention type: Device
intervention name: Medline Pediatric Face Masks
description: Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
arm group label: Children 10-12 yrs
arm group label: Children 4-5 yrs
arm group label: Children 6-9 yrs
intervention type: Device
intervention name: KC Childs Mask
description: KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
arm group label: Children 10-12 yrs
arm group label: Children 4-5 yrs
arm group label: Children 6-9 yrs
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward Drower, MS
role: Principal Investigator
affiliation: Medline Industries Inc
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 