<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/NCT03785977</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00055260</org_study_id>
    <nct_id>NCT03785977</nct_id>
  </id_info>
  <brief_title>Airway Deadspace in Children: Air-Q Versus Endotracheal Tube</brief_title>
  <official_title>A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study will be to measure the airway deadspace associated with use of&#xD;
      appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing&#xD;
      between 5 and 20 kg and compare that to the airway deadspace associated with use of an&#xD;
      endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an increasing interest in the use of supraglottic airway devices in progressively&#xD;
      younger and younger patients. One issue that has not been well evaluated is the contribution&#xD;
      of these devices to airway dead space in young children and infants. Volumetric capnography&#xD;
      is the only non-invasive technology available at the current time to evaluate airway&#xD;
      deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the&#xD;
      expired waveform one can determine different respiratory parameters including dead space.&#xD;
      This is clinically important in young children as the clinician begins to evaluate whether or&#xD;
      not to use an endotracheal tube or supraglottic airway in these patients. To perform this&#xD;
      investigation the study team will use volumetric capnography to examine the airway dead space&#xD;
      associated with these devices during and elective general surgery and urologic procedures in&#xD;
      healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).&#xD;
&#xD;
      Participants in the study will be given ETT or Air-Q as an intervention, but the investigator&#xD;
      does not assign specific interventions to the study participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</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>Mean Value of Airway Dead Space</measure>
    <time_frame>10 minutes</time_frame>
    <description>A mean value observed over the first 10 minutes following placement of the ETT or the AirQ at the beginning of the case will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung Compliance measured by Respironics NM3 respiratory monitors</measure>
    <time_frame>10 minutes</time_frame>
    <description>The values of lung compliance will be collected and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Resistance measured by Respironics NM3 respiratory monitors</measure>
    <time_frame>10 minutes</time_frame>
    <description>The value of resistance to flow in the airways will be collected and reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Carbon Dioxide Associated with the Devices</measure>
    <time_frame>10 minutes</time_frame>
    <description>The volume of carbon dioxide associated with the devices will be recorded and reported.</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Airway Deadspace</condition>
  <arm_group>
    <arm_group_label>Air-Q 5-9kg</arm_group_label>
    <description>Participants weighing 5-9kg may be chosen to wear the Air-Q device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air-Q 10-14kg</arm_group_label>
    <description>Participants weighing 10-14kg may be chosen to wear the Air-Q device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air-Q 15-20kg</arm_group_label>
    <description>Participants weighing 15-20kg may be chosen to wear the Air-Q device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ETT 5-9kg</arm_group_label>
    <description>Participants weighing 5-9kg may be chosen to wear the ETT device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ETT 10-14kg</arm_group_label>
    <description>Participants weighing 10-14kg may be chosen to wear the ETT device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ETT 15-20kg</arm_group_label>
    <description>Participants weighing 15-20kg may be chosen to wear the ETT device.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        To perform this investigation we will use volumetric capnography to examine the airway dead&#xD;
        space associated with these devices during and elective general surgery and urologic&#xD;
        procedures in healthy children between the ages of 0 and 5 years of age (roughly 5-20 kg).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 3 months and 6 years of age weighing between 5 and 20 kg&#xD;
&#xD;
          -  Patient presenting outpatient urologic or general surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of difficult airway/intubation&#xD;
&#xD;
          -  Patients suspected to have a difficult airway.&#xD;
&#xD;
          -  Morbid obesity BMI &gt;39&#xD;
&#xD;
          -  Emergency status of surgery&#xD;
&#xD;
          -  Patients exposed to second hand smoke&#xD;
&#xD;
          -  Patients with Asthma&#xD;
&#xD;
          -  Patients with a URI symptom such as nasal drainage, cough, or fever within 7 days of&#xD;
             the date of surgery&#xD;
&#xD;
          -  History of Prematurity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Templeton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Micaglio M, Bonato R, De Nardin M, Parotto M, Trevisanuto D, Zanardo V, Doglioni N, Ori C. Prospective, randomized comparison of ProSeal and Classic laryngeal mask airways in anaesthetized neonates and infants. Br J Anaesth. 2009 Aug;103(2):263-7. doi: 10.1093/bja/aep106. Epub 2009 May 19.</citation>
    <PMID>19454544</PMID>
  </reference>
  <reference>
    <citation>Templeton TW, Hoke LK, Templeton LB, Ririe DG, Rose DM, Bryan YF. A comparison of 3 ventilation strategies in children younger than 1 year using a Proseal laryngeal mask airway: a randomized controlled trial. J Clin Anesth. 2016 Dec;35:502-508. doi: 10.1016/j.jclinane.2016.07.042. Epub 2016 Oct 19.</citation>
    <PMID>27871584</PMID>
  </reference>
  <reference>
    <citation>Garcia-Fernandez J, Tusman G, Suarez-Sipmann F, Llorens J, Soro M, Belda JF. Programming pressure support ventilation in pediatric patients in ambulatory surgery with a laryngeal mask airway. Anesth Analg. 2007 Dec;105(6):1585-91, table of contents. doi: 10.1213/01.ane.0000287674.64086.f1.</citation>
    <PMID>18042854</PMID>
  </reference>
  <reference>
    <citation>Drake-Brockman TF, Ramgolam A, Zhang G, Hall GL, von Ungern-Sternberg BS. The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial. Lancet. 2017 Feb 18;389(10070):701-708. doi: 10.1016/S0140-6736(16)31719-6. Epub 2017 Jan 18.</citation>
    <PMID>28108038</PMID>
  </reference>
  <reference>
    <citation>Casati A, Fanelli G, Torri G. Physiological dead space/tidal volume ratio during face mask, laryngeal mask, and cuffed oropharyngeal airway spontaneous ventilation. J Clin Anesth. 1998 Dec;10(8):652-5. doi: 10.1016/s0952-8180(98)00108-1.</citation>
    <PMID>9873966</PMID>
  </reference>
  <reference>
    <citation>Templeton TW, Goenaga-Diaz EJ, Templeton LB, Ririe DG. An in vitro analysis of the dead space in 5 supraglottic airway devices intended for use in small children and infants. Paediatr Anaesth. 2018 Jun;28(6):570-572. doi: 10.1111/pan.13382. No abstract available.</citation>
    <PMID>29878544</PMID>
  </reference>
  <reference>
    <citation>Templeton TW, Hoke LK, Yaung J, Aschenbrenner CA, Rose DM, Templeton LB, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. J Clin Anesth. 2016 Nov;34:272-8. doi: 10.1016/j.jclinane.2016.04.031. Epub 2016 May 15.</citation>
    <PMID>27687391</PMID>
  </reference>
  <reference>
    <citation>Al-Subu A, Jooste E, Hornik CP, Fleming GA, Cheifetz IM, Ofori-Amanfo G. Correlation between minute carbon dioxide elimination and pulmonary blood flow in single-ventricle patients after stage 1 palliation and 2-ventricle patients with intracardiac shunts: A pilot study. Paediatr Anaesth. 2018 Jul;28(7):618-624. doi: 10.1111/pan.13423.</citation>
    <PMID>30133920</PMID>
  </reference>
  <reference>
    <citation>Ream RS, Schreiner MS, Neff JD, McRae KM, Jawad AF, Scherer PW, Neufeld GR. Volumetric capnography in children. Influence of growth on the alveolar plateau slope. Anesthesiology. 1995 Jan;82(1):64-73. doi: 10.1097/00000542-199501000-00010.</citation>
    <PMID>7832337</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ventilation</keyword>
  <keyword>pediatrics</keyword>
  <keyword>airway management</keyword>
  <keyword>respiration</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/NCT03785977
org study id: IRB00055260
nct id: NCT03785977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this study will be to measure the airway deadspace associated with use of
      appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing
      between 5 and 20 kg and compare that to the airway deadspace associated with use of an
      endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.
There is an increasing interest in the use of supraglottic airway devices in progressively
      younger and younger patients. One issue that has not been well evaluated is the contribution
      of these devices to airway dead space in young children and infants. Volumetric capnography
      is the only non-invasive technology available at the current time to evaluate airway
      deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the
      expired waveform one can determine different respiratory parameters including dead space.
      This is clinically important in young children as the clinician begins to evaluate whether or
      not to use an endotracheal tube or supraglottic airway in these patients. To perform this
      investigation the study team will use volumetric capnography to examine the airway dead space
      associated with these devices during and elective general surgery and urologic procedures in
      healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

      Participants in the study will be given ETT or Air-Q as an intervention, but the investigator
      does not assign specific interventions to the study participants.
observational model: Case-Only
time perspective: Prospective
measure: Mean Value of Airway Dead Space
time frame: 10 minutes
description: A mean value observed over the first 10 minutes following placement of the ETT or the AirQ at the beginning of the case will be recorded.
measure: Lung Compliance measured by Respironics NM3 respiratory monitors
time frame: 10 minutes
description: The values of lung compliance will be collected and reported.
measure: Airway Resistance measured by Respironics NM3 respiratory monitors
time frame: 10 minutes
description: The value of resistance to flow in the airways will be collected and reported
measure: Volume of Carbon Dioxide Associated with the Devices
time frame: 10 minutes
description: The volume of carbon dioxide associated with the devices will be recorded and reported.
arm group label: Air-Q 5-9kg
description: Participants weighing 5-9kg may be chosen to wear the Air-Q device.
arm group label: Air-Q 10-14kg
description: Participants weighing 10-14kg may be chosen to wear the Air-Q device.
arm group label: Air-Q 15-20kg
description: Participants weighing 15-20kg may be chosen to wear the Air-Q device.
arm group label: ETT 5-9kg
description: Participants weighing 5-9kg may be chosen to wear the ETT device.
arm group label: ETT 10-14kg
description: Participants weighing 10-14kg may be chosen to wear the ETT device.
arm group label: ETT 15-20kg
description: Participants weighing 15-20kg may be chosen to wear the ETT device.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Templeton, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Micaglio M, Bonato R, De Nardin M, Parotto M, Trevisanuto D, Zanardo V, Doglioni N, Ori C. Prospective, randomized comparison of ProSeal and Classic laryngeal mask airways in anaesthetized neonates and infants. Br J Anaesth. 2009 Aug;103(2):263-7. doi: 10.1093/bja/aep106. Epub 2009 May 19.
PMID: 19454544
citation: Templeton TW, Hoke LK, Templeton LB, Ririe DG, Rose DM, Bryan YF. A comparison of 3 ventilation strategies in children younger than 1 year using a Proseal laryngeal mask airway: a randomized controlled trial. J Clin Anesth. 2016 Dec;35:502-508. doi: 10.1016/j.jclinane.2016.07.042. Epub 2016 Oct 19.
PMID: 27871584
citation: Garcia-Fernandez J, Tusman G, Suarez-Sipmann F, Llorens J, Soro M, Belda JF. Programming pressure support ventilation in pediatric patients in ambulatory surgery with a laryngeal mask airway. Anesth Analg. 2007 Dec;105(6):1585-91, table of contents. doi: 10.1213/01.ane.0000287674.64086.f1.
PMID: 18042854
citation: Drake-Brockman TF, Ramgolam A, Zhang G, Hall GL, von Ungern-Sternberg BS. The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial. Lancet. 2017 Feb 18;389(10070):701-708. doi: 10.1016/S0140-6736(16)31719-6. Epub 2017 Jan 18.
PMID: 28108038
citation: Casati A, Fanelli G, Torri G. Physiological dead space/tidal volume ratio during face mask, laryngeal mask, and cuffed oropharyngeal airway spontaneous ventilation. J Clin Anesth. 1998 Dec;10(8):652-5. doi: 10.1016/s0952-8180(98)00108-1.
PMID: 9873966
citation: Templeton TW, Goenaga-Diaz EJ, Templeton LB, Ririe DG. An in vitro analysis of the dead space in 5 supraglottic airway devices intended for use in small children and infants. Paediatr Anaesth. 2018 Jun;28(6):570-572. doi: 10.1111/pan.13382. No abstract available.
PMID: 29878544
citation: Templeton TW, Hoke LK, Yaung J, Aschenbrenner CA, Rose DM, Templeton LB, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. J Clin Anesth. 2016 Nov;34:272-8. doi: 10.1016/j.jclinane.2016.04.031. Epub 2016 May 15.
PMID: 27687391
citation: Al-Subu A, Jooste E, Hornik CP, Fleming GA, Cheifetz IM, Ofori-Amanfo G. Correlation between minute carbon dioxide elimination and pulmonary blood flow in single-ventricle patients after stage 1 palliation and 2-ventricle patients with intracardiac shunts: A pilot study. Paediatr Anaesth. 2018 Jul;28(7):618-624. doi: 10.1111/pan.13423.
PMID: 30133920
citation: Ream RS, Schreiner MS, Neff JD, McRae KM, Jawad AF, Scherer PW, Neufeld GR. Volumetric capnography in children. Influence of growth on the alveolar plateau slope. Anesthesiology. 1995 Jan;82(1):64-73. doi: 10.1097/00000542-199501000-00010.
PMID: 7832337
responsible party type: Sponsor
sharing ipd: No