<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/NCT03301324</url>
  </required_header>
  <id_info>
    <org_study_id>7701</org_study_id>
    <nct_id>NCT03301324</nct_id>
  </id_info>
  <brief_title>Intubation Assist Clinical Study</brief_title>
  <official_title>Intubation Assist Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zoll Medical Corporation</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Intubation Assist Clinical Study is an observational study of adult patients scheduled&#xD;
      for elective surgery under general anesthesia to assess the user interface, assess&#xD;
      transthoracic impedance by the ventilation volume and assess transthoracic impedance.&#xD;
      Monitoring will begin at the time the patient is pre-oxygenated in preparation for&#xD;
      endotracheal intubation and will continue until 30 minutes after intubation is achieved.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">September 20, 2017</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>Assessment of the user interface</measure>
    <time_frame>Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of transthoracic impedance</measure>
    <time_frame>Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">66</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intubation Assist Dashboard</intervention_name>
    <description>The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients scheduled for elective surgery using general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Requiring intubation and assisted ventilation&#xD;
&#xD;
          -  Patient undergoing elective surgery&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin condition that would interfere with electrodes&#xD;
&#xD;
          -  Inability/failure to intubate&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Surgery that prevents the application of electrodes and monitoring equipment.&#xD;
&#xD;
          -  Previous excision of complete or partial lung; congenital lung abnormalities.&#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_official>
    <last_name>Lars Wik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Kramer-Johansen J, Eilevstjonn J, Olasveengen TM, Tomlinson AE, Dorph E, Steen PA. Transthoracic impedance changes as a tool to detect malpositioned tracheal tubes. Resuscitation. 2008 Jan;76(1):11-6. doi: 10.1016/j.resuscitation.2007.07.021. Epub 2007 Aug 23.</citation>
    <PMID>17719166</PMID>
  </reference>
  <reference>
    <citation>Losert H, Risdal M, Sterz F, Nysaether J, Kohler K, Eftestol T, Wandaller C, Myklebust H, Uray T, Sodeck G, Laggner AN. Thoracic impedance changes measured via defibrillator pads can monitor ventilation in critically ill patients and during cardiopulmonary resuscitation. Crit Care Med. 2006 Sep;34(9):2399-405. doi: 10.1097/01.CCM.0000235666.40378.60.</citation>
    <PMID>16850000</PMID>
  </reference>
  <reference>
    <citation>Roberts K, Srinivasan V, Niles DE, Eilevstjonn J, Tyler L, Boyle L, Bishnoi R, Ferry S, Nysaether J, Stavland M, Litman RS, Helfaer M, Nadkarni V. Does change in thoracic impedance measured via defibrillator electrode pads accurately detect ventilation breaths in children? Resuscitation. 2010 Nov;81(11):1544-9. doi: 10.1016/j.resuscitation.2010.07.010. Epub 2010 Aug 25.</citation>
    <PMID>20800333</PMID>
  </reference>
  <reference>
    <citation>Hamilton LH, Beard JD, Kory RC. Impedance measurement of tidal volume and ventilation. J Appl Physiol. 1965 May;20(3):565-8. doi: 10.1152/jappl.1965.20.3.565. No abstract available.</citation>
    <PMID>5837579</PMID>
  </reference>
  <reference>
    <citation>Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.</citation>
    <PMID>15271750</PMID>
  </reference>
  <reference>
    <citation>Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.</citation>
    <PMID>16850003</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intubation</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/NCT03301324
org study id: 7701
nct id: NCT03301324
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The Intubation Assist Clinical Study is an observational study of adult patients scheduled
      for elective surgery under general anesthesia to assess the user interface, assess
      transthoracic impedance by the ventilation volume and assess transthoracic impedance.
      Monitoring will begin at the time the patient is pre-oxygenated in preparation for
      endotracheal intubation and will continue until 30 minutes after intubation is achieved.
observational model: Cohort
time perspective: Prospective
measure: Assessment of the user interface
time frame: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation
measure: Assessment of transthoracic impedance
time frame: Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation
intervention type: Device
intervention name: Intubation Assist Dashboard
description: The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Wik, MD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
citation: Kramer-Johansen J, Eilevstjonn J, Olasveengen TM, Tomlinson AE, Dorph E, Steen PA. Transthoracic impedance changes as a tool to detect malpositioned tracheal tubes. Resuscitation. 2008 Jan;76(1):11-6. doi: 10.1016/j.resuscitation.2007.07.021. Epub 2007 Aug 23.
PMID: 17719166
citation: Losert H, Risdal M, Sterz F, Nysaether J, Kohler K, Eftestol T, Wandaller C, Myklebust H, Uray T, Sodeck G, Laggner AN. Thoracic impedance changes measured via defibrillator pads can monitor ventilation in critically ill patients and during cardiopulmonary resuscitation. Crit Care Med. 2006 Sep;34(9):2399-405. doi: 10.1097/01.CCM.0000235666.40378.60.
PMID: 16850000
citation: Roberts K, Srinivasan V, Niles DE, Eilevstjonn J, Tyler L, Boyle L, Bishnoi R, Ferry S, Nysaether J, Stavland M, Litman RS, Helfaer M, Nadkarni V. Does change in thoracic impedance measured via defibrillator electrode pads accurately detect ventilation breaths in children? Resuscitation. 2010 Nov;81(11):1544-9. doi: 10.1016/j.resuscitation.2010.07.010. Epub 2010 Aug 25.
PMID: 20800333
citation: Hamilton LH, Beard JD, Kory RC. Impedance measurement of tidal volume and ventilation. J Appl Physiol. 1965 May;20(3):565-8. doi: 10.1152/jappl.1965.20.3.565. No abstract available.
PMID: 5837579
citation: Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PMID: 15271750
citation: Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.
PMID: 16850003
responsible party type: Sponsor
sharing ipd: No