<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/NCT03025490</url>
  </required_header>
  <id_info>
    <org_study_id>EPCAPNO-HMO-CTIL</org_study_id>
    <nct_id>NCT03025490</nct_id>
  </id_info>
  <brief_title>The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory</brief_title>
  <official_title>The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covidien Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <brief_summary>
    <textblock>
      The study sets out to assess whether in the context of nurse administered procedural sedation&#xD;
      in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index&#xD;
      results in lower incidence of severe adverse respiratory events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the electrophysiology lab, the use of procedural sedation, often by nurses is considered&#xD;
      routine and safe.Standard monitoring during these procedures includes continuous Oxygen&#xD;
      Saturation (SpO2), Heart Rate and rhythm and interval Respiratory rate and blood pressure.&#xD;
&#xD;
      Capnography allows for continuous monitoring of exhaled carbon dioxide, it is an important&#xD;
      tool during anesthesia, providing valuable information on the patient's respiratory status&#xD;
      and is standard equipment in most operating rooms. Its use in procedural sedation has&#xD;
      increased over the past years as the body of evidence supporting this practice has been&#xD;
      growing.&#xD;
&#xD;
      It has been previously shown, use of capnography may allow for earlier detection of&#xD;
      respiratory adverse events in various types of procedural sedation. The fall of oxygen&#xD;
      saturation can occur very late during an adverse respiratory event, especially if&#xD;
      supplemental oxygen is given. Today's procedural sedation in the electrophysiology&#xD;
      catheterization lab are more complex, patients are of increasingly older age, have more&#xD;
      comorbidities, procedures are lengthier and often require deeper sedation (i.e. during&#xD;
      complex ablation procedures).&#xD;
&#xD;
      The use of capnography in the electrophysiology lab has not been addressed thoroughly in the&#xD;
      literature. A recent multidisciplinary review of anesthesia in the electrophysiology lab&#xD;
      states: &quot;In the obstructive sleep apnea or non-obstructive sleep apnea patient, capnography&#xD;
      should ideally be employed throughout the sedation period.&quot;…&quot;Capnography appears to be&#xD;
      underutilized in the electrophysiology lab, given its omission from electrophysiology&#xD;
      literature documenting safety of sedation by non-anesthesiologists&quot; We hypothesize that the&#xD;
      routine use of capnography during nurse administered procedural sedations in the&#xD;
      electrophysiology lab could aid in detection of early signs of adverse respiratory events,&#xD;
      thus allowing early intervention and reduction of these events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Sentinel Adverse Respiratory Events (AREs)</measure>
    <time_frame>One month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean time to detection of a Sentinel or Moderate ARE</measure>
    <time_frame>One month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Moderate Adverse Respiratory Event</measure>
    <time_frame>One month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Minor Adverse Respiratory Event</measure>
    <time_frame>One month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Minimal Adverse Respiratory Event</measure>
    <time_frame>One month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total rate of Adverse Respiratory Event</measure>
    <time_frame>One month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Capnography</condition>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient undergoing sedation, treatment team does not have capnography data available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capnography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient undergoing sedation, treatment team does have capnography data available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capnographic monitoring</intervention_name>
    <description>Capnographic monitoring is used during the sedation.</description>
    <arm_group_label>Capnography</arm_group_label>
    <other_name>Capnography</other_name>
    <other_name>Integrated Pulmonary Index</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is 18 years of age or older&#xD;
&#xD;
          2. Patient is scheduled to undergo nurse administered procedural sedation in the&#xD;
             electrophysiology laboratory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is scheduled for anesthesiology based anesthesia.&#xD;
&#xD;
          2. Patient requires ventilator support at baseline (i.e. intubated patient, Bilevel&#xD;
             Positive Airway Pressure or continuous positive airway pressure devices are in use)&#xD;
&#xD;
          3. Patient presents to electrophysiology laboratory with capnography monitoring in place.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Luria, MD</last_name>
    <phone>00 972 2 6778651</phone>
    <email>dluria@hadassah.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emmanuel S Sirat, B.Med.Sc</last_name>
    <phone>00 972 50 3377276</phone>
    <email>emmanuel.sirat@mail.huji.ac.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem District</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Hadas Lemberg, PhD</last_name>
      <phone>00 972 2 6777572</phone>
      <email>lhadas@hadassah.org.il</email>
    </contact>
    <investigator>
      <last_name>David Luria, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanuel S Sirat, B.Med.Sc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Capnography</keyword>
  <keyword>Electrophysiology</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025490
org study id: EPCAPNO-HMO-CTIL
nct id: NCT03025490
lead sponsor: 
collaborator: 
The study sets out to assess whether in the context of nurse administered procedural sedation
      in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index
      results in lower incidence of severe adverse respiratory events.
In the electrophysiology lab, the use of procedural sedation, often by nurses is considered
      routine and safe.Standard monitoring during these procedures includes continuous Oxygen
      Saturation (SpO2), Heart Rate and rhythm and interval Respiratory rate and blood pressure.

      Capnography allows for continuous monitoring of exhaled carbon dioxide, it is an important
      tool during anesthesia, providing valuable information on the patient's respiratory status
      and is standard equipment in most operating rooms. Its use in procedural sedation has
      increased over the past years as the body of evidence supporting this practice has been
      growing.

      It has been previously shown, use of capnography may allow for earlier detection of
      respiratory adverse events in various types of procedural sedation. The fall of oxygen
      saturation can occur very late during an adverse respiratory event, especially if
      supplemental oxygen is given. Today's procedural sedation in the electrophysiology
      catheterization lab are more complex, patients are of increasingly older age, have more
      comorbidities, procedures are lengthier and often require deeper sedation (i.e. during
      complex ablation procedures).

      The use of capnography in the electrophysiology lab has not been addressed thoroughly in the
      literature. A recent multidisciplinary review of anesthesia in the electrophysiology lab
      states: "In the obstructive sleep apnea or non-obstructive sleep apnea patient, capnography
      should ideally be employed throughout the sedation period."…"Capnography appears to be
      underutilized in the electrophysiology lab, given its omission from electrophysiology
      literature documenting safety of sedation by non-anesthesiologists" We hypothesize that the
      routine use of capnography during nurse administered procedural sedations in the
      electrophysiology lab could aid in detection of early signs of adverse respiratory events,
      thus allowing early intervention and reduction of these events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rate of Sentinel Adverse Respiratory Events (AREs)
time frame: One month
measure: Mean time to detection of a Sentinel or Moderate ARE
time frame: One month
measure: Rate of Moderate Adverse Respiratory Event
time frame: One month
measure: Rate of Minor Adverse Respiratory Event
time frame: One month
measure: Rate of Minimal Adverse Respiratory Event
time frame: One month
measure: Total rate of Adverse Respiratory Event
time frame: One month
arm group label: standard of Care
arm group type: No Intervention
description: Patient undergoing sedation, treatment team does not have capnography data available.
arm group label: Capnography
arm group type: Experimental
description: Patient undergoing sedation, treatment team does have capnography data available.
intervention type: Device
intervention name: Capnographic monitoring
description: Capnographic monitoring is used during the sedation.
arm group label: Capnography
other name: Capnography
other name: Integrated Pulmonary Index
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Luria, MD
phone: 00 972 2 6778651
email: dluria@hadassah.org.il
last name: Emmanuel S Sirat, B.Med.Sc
phone: 00 972 50 3377276
email: emmanuel.sirat@mail.huji.ac.il
facility: 
contact: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor
sharing ipd: No