<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/NCT03038074</url>
  </required_header>
  <id_info>
    <org_study_id>BAIL0002</org_study_id>
    <nct_id>NCT03038074</nct_id>
  </id_info>
  <brief_title>Plethysmographic and Acoustic Respiration Rate Clinical Data Collection</brief_title>
  <official_title>Plethysmographic and Acoustic Respiration Rate Clinical Data Collection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical investigation is to collect high-resolution pulse oximetry,&#xD;
      RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to&#xD;
      build a database of representative pulse oximetry and respiratory signal profiles for&#xD;
      patients in this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of high-resolution pulse oximetry and RAM data in pediatric subjects</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Oximeter with respiration rate sensor</intervention_name>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 0 to 5 years old&#xD;
&#xD;
          -  Fully developed skin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with skin abnormalities at the planned application sites that would interfere&#xD;
             with sensor application.&#xD;
&#xD;
          -  Subjects with pre-existing conditions and/or co-morbidities that would prohibit them&#xD;
             from participating in the study due to unacceptable risks to their health and&#xD;
             well-being, as determined by the Principal Investigator (PI).&#xD;
&#xD;
          -  Subjects deemed not suitable for the study at the discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Office of Mohammad T. Bailony</name>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <disposition_first_submitted>March 14, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 14, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 11, 2021</disposition_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03038074
org study id: BAIL0002
nct id: NCT03038074
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The objective of this clinical investigation is to collect high-resolution pulse oximetry,
      RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to
      build a database of representative pulse oximetry and respiratory signal profiles for
      patients in this population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Collection of high-resolution pulse oximetry and RAM data in pediatric subjects
time frame: through study completion, an average of 6 months
description: The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.
arm group label: Test Group
arm group type: Experimental
description: The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate.
intervention type: Device
intervention name: Pulse Oximeter with respiration rate sensor
arm group label: Test Group
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor