<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/NCT03275324</url>
  </required_header>
  <id_info>
    <org_study_id>1037010</org_study_id>
    <nct_id>NCT03275324</nct_id>
  </id_info>
  <brief_title>Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients</brief_title>
  <official_title>Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which&#xD;
      measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry&#xD;
      (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.&#xD;
&#xD;
      The integrated pulmonary index (IPI) is an algorithm driven parameter derived from&#xD;
      non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a&#xD;
      value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal&#xD;
      range.&#xD;
&#xD;
      The purpose of this observational study is to determine if the IPI is associated with&#xD;
      complications in the immediate postoperative period.&#xD;
&#xD;
      The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to&#xD;
      the IPI therefore this device will not be used to guide care in any way.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Postoperative Respiratory Event</measure>
    <time_frame>Up to 2 hours</time_frame>
    <description>Respiratory complications occurring after surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Enrolled patients</arm_group_label>
    <description>Surgical patients meeting enrollment criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capnostream20p</intervention_name>
    <description>Observational study of patients connected to the Capnostream20p monitor.</description>
    <arm_group_label>Enrolled patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgical patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18 years or older Planned to undergo general anesthesia for surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant Inability to consent Mechanically ventilated prior to surgery&#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>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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/NCT03275324
org study id: 1037010
nct id: NCT03275324
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which
      measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry
      (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.

      The integrated pulmonary index (IPI) is an algorithm driven parameter derived from
      non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a
      value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal
      range.

      The purpose of this observational study is to determine if the IPI is associated with
      complications in the immediate postoperative period.

      The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to
      the IPI therefore this device will not be used to guide care in any way.
observational model: Cohort
time perspective: Prospective
measure: Postoperative Respiratory Event
time frame: Up to 2 hours
description: Respiratory complications occurring after surgery
arm group label: Enrolled patients
description: Surgical patients meeting enrollment criteria
intervention type: Device
intervention name: Capnostream20p
description: Observational study of patients connected to the Capnostream20p monitor.
arm group label: Enrolled patients
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: Postoperative Complications