<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/NCT03043911</url>
  </required_header>
  <id_info>
    <org_study_id>014-293</org_study_id>
    <nct_id>NCT03043911</nct_id>
  </id_info>
  <brief_title>Improved Patient Safety Through Continuous Bi-channel RR and SpO2 Monitoring With Masimo Patient SafetyNet</brief_title>
  <acronym>SafetyNet</acronym>
  <official_title>Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator intend to perform an observational study, by adding Respiratory Rate&#xD;
      monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and&#xD;
      PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be&#xD;
      deactivated. Retrospective analysis of the observational data collected will be utilized to&#xD;
      evaluate the potential benefits of additional continuous respiratory rate monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Addition of acoustic respiratory rate monitoring to an already existing standard of care&#xD;
      patient surveillance system that includes oxygen saturation and heart rate monitoring by&#xD;
      pulse oximetry will result in earlier and more sensitive detection of respiratory events and&#xD;
      possibly early stages of developing sepsis in a post-surgical/orthopedic study population.&#xD;
&#xD;
      An observational study with RRa is an additional blinded parameter to the already existing&#xD;
      standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and&#xD;
      orthopedic patients), where patients receive opioids for pain management. 300 consecutive&#xD;
      patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery,&#xD;
      after discharge from the Recovery Room, &amp; upon admission to the Surgical floor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events</measure>
    <time_frame>with in 24 hours post surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis.</measure>
    <time_frame>with in 24 hours post surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Signs and Symptoms, Respiratory</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients to be admitted to the general post surgical floor who meet the inclusion and&#xD;
        exclusion criteria will be enrolled after signing the study consent form.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Adult 18yrs of age or older&#xD;
&#xD;
               -  Post-surgical patient receiving opioid pain medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor&#xD;
             placement&#xD;
&#xD;
               -  Finger or skin abnormalities at sensor sites&#xD;
&#xD;
               -  Expected opioid therapy duration less than 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>June 9, 2017</last_update_submitted>
  <last_update_submitted_qc>June 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early detection</keyword>
  <keyword>respiratory events</keyword>
  <keyword>sepsis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
  </condition_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/NCT03043911
org study id: 014-293
nct id: NCT03043911
lead sponsor: 
collaborator: 
has dmc: No
The investigator intend to perform an observational study, by adding Respiratory Rate
      monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and
      PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be
      deactivated. Retrospective analysis of the observational data collected will be utilized to
      evaluate the potential benefits of additional continuous respiratory rate monitoring.
Addition of acoustic respiratory rate monitoring to an already existing standard of care
      patient surveillance system that includes oxygen saturation and heart rate monitoring by
      pulse oximetry will result in earlier and more sensitive detection of respiratory events and
      possibly early stages of developing sepsis in a post-surgical/orthopedic study population.

      An observational study with RRa is an additional blinded parameter to the already existing
      standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and
      orthopedic patients), where patients receive opioids for pain management. 300 consecutive
      patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery,
      after discharge from the Recovery Room, & upon admission to the Surgical floor.
observational model: Case-Only
time perspective: Prospective
measure: Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events
time frame: with in 24 hours post surgery
measure: Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis.
time frame: with in 24 hours post surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Signs and Symptoms, Respiratory