<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/NCT03822689</url>
  </required_header>
  <id_info>
    <org_study_id>19MMHIS025e</org_study_id>
    <nct_id>NCT03822689</nct_id>
  </id_info>
  <brief_title>Comparison of Ventilation Tubes Among Anesthetized Pediatrics</brief_title>
  <official_title>The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To discover whether different types of ventilation breathing tube influence ventilation&#xD;
      effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon&#xD;
      dioxide, compliance among children and neonate under general anesthesia. The study compares&#xD;
      eight ventilator breathing tube of different length, diameter, material of the ventilator&#xD;
      breathing tube. Besides, the investigators also make an approach verify the change of body&#xD;
      temperate under different gas flow(2L, and 5L).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In previous research, initial mechanical ventilator settings about children were as&#xD;
      following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of&#xD;
      respiratory pressure should be &lt;10 cmH2O in healthy patients; 3. respiratory pressures could&#xD;
      be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory&#xD;
      pressure was necessary, although the optimal level is unknown.&#xD;
&#xD;
      However, few researches discussed about Influences of different types of ventilation&#xD;
      breathing tube. The investigators want to clarify the character about length, diameter, and&#xD;
      material of the ventilation breathing tube under the ventilation system in relation to tidal&#xD;
      volume, end tidal carbon dioxide, compliance among children and neonate.&#xD;
&#xD;
      During this study, the participants will be 100 children who were ASA class1, 2 and performed&#xD;
      non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants&#xD;
      will divide into three groups according to different body weights (Group N: &lt;4.5kg; Group T:&#xD;
      4.5~20kg; Group C: &gt;20kg), and would receipt total eight type of ventilator breathing tube&#xD;
      test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and&#xD;
      compliance. Besides, secondary outcome will be the change of body temperate under different&#xD;
      gas flow (2L, and 5L).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Institutional Review Board did not approve&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tidal volume</measure>
    <time_frame>From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning</time_frame>
    <description>compared tidal volume besides different ventilation breathing tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End tidal carbon dioxide</measure>
    <time_frame>From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning</time_frame>
    <description>compared End tidal carbon dioxide besides different ventilation breathing tube</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body temperate</measure>
    <time_frame>From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning</time_frame>
    <description>compared Body temperate about different gas flow(2L,5L)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Ventilation</condition>
  <arm_group>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gas flow:5L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube F2220</intervention_name>
    <description>M: Folding D: 22mm; L: 2.0M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube F2216</intervention_name>
    <description>M: Folding; D: 22mm; L:1.6M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube F1520</intervention_name>
    <description>M: Folding; D: 15mm; L:2.0M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube F1516</intervention_name>
    <description>M: Folding; D: 15mm; L:1.6M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube U1016</intervention_name>
    <description>M: Unfolding; D: 10mm; L:1.6M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube U1516</intervention_name>
    <description>M: Unfolding; D: 15mm; L:1.6M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube CA20</intervention_name>
    <description>M: Co-axis; L:2.0M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator breathing tube CA16</intervention_name>
    <description>M: Co-axis; L:1.6M</description>
    <arm_group_label>Gas flow:2L</arm_group_label>
    <arm_group_label>Gas flow:5L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with American Society of Anesthesiologists (ASA) physical status classification 1&amp;2&#xD;
&#xD;
          -  undergo elective surgery&#xD;
&#xD;
          -  intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac-pulmonary surgery&#xD;
&#xD;
          -  Had respiratory related disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Chung Huang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.</citation>
    <PMID>25625261</PMID>
  </reference>
  <reference>
    <citation>Kneyber MC. Intraoperative mechanical ventilation for the pediatric patient. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):371-9. doi: 10.1016/j.bpa.2015.10.001. Epub 2015 Oct 14.</citation>
    <PMID>26643101</PMID>
  </reference>
  <reference>
    <citation>Glenski TA, Diehl C, Clopton RG, Friesen RH. Breathing circuit compliance and accuracy of displayed tidal volume during pressure-controlled ventilation of infants: A quality improvement project. Paediatr Anaesth. 2017 Sep;27(9):935-941. doi: 10.1111/pan.13164. Epub 2017 May 15.</citation>
    <PMID>28504341</PMID>
  </reference>
  <reference>
    <citation>von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.</citation>
    <PMID>15673856</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chien-Chung,Huang</investigator_full_name>
    <investigator_title>attending physician, department of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>Ventilation breathing tube</keyword>
  <keyword>End-Tidal Carbon Dioxide</keyword>
  <keyword>Heart rate</keyword>
  <keyword>tidal volume</keyword>
  <keyword>blood temperature</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/NCT03822689
org study id: 19MMHIS025e
nct id: NCT03822689
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To discover whether different types of ventilation breathing tube influence ventilation
      effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon
      dioxide, compliance among children and neonate under general anesthesia. The study compares
      eight ventilator breathing tube of different length, diameter, material of the ventilator
      breathing tube. Besides, the investigators also make an approach verify the change of body
      temperate under different gas flow(2L, and 5L).
In previous research, initial mechanical ventilator settings about children were as
      following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of
      respiratory pressure should be <10 cmH2O in healthy patients; 3. respiratory pressures could
      be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory
      pressure was necessary, although the optimal level is unknown.

      However, few researches discussed about Influences of different types of ventilation
      breathing tube. The investigators want to clarify the character about length, diameter, and
      material of the ventilation breathing tube under the ventilation system in relation to tidal
      volume, end tidal carbon dioxide, compliance among children and neonate.

      During this study, the participants will be 100 children who were ASA class1, 2 and performed
      non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants
      will divide into three groups according to different body weights (Group N: <4.5kg; Group T:
      4.5~20kg; Group C: >20kg), and would receipt total eight type of ventilator breathing tube
      test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and
      compliance. Besides, secondary outcome will be the change of body temperate under different
      gas flow (2L, and 5L).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Tidal volume
time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
description: compared tidal volume besides different ventilation breathing tube
measure: End tidal carbon dioxide
time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
description: compared End tidal carbon dioxide besides different ventilation breathing tube
measure: Body temperate
time frame: From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning
description: compared Body temperate about different gas flow(2L,5L)
arm group label: Gas flow:2L
arm group type: Active Comparator
description: use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M
arm group label: Gas flow:5L
arm group type: Active Comparator
description: use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M
intervention type: Device
intervention name: Ventilator breathing tube F2220
description: M: Folding D: 22mm; L: 2.0M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube F2216
description: M: Folding; D: 22mm; L:1.6M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube F1520
description: M: Folding; D: 15mm; L:2.0M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube F1516
description: M: Folding; D: 15mm; L:1.6M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube U1016
description: M: Unfolding; D: 10mm; L:1.6M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube U1516
description: M: Unfolding; D: 15mm; L:1.6M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube CA20
description: M: Co-axis; L:2.0M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
intervention type: Device
intervention name: Ventilator breathing tube CA16
description: M: Co-axis; L:1.6M
arm group label: Gas flow:2L
arm group label: Gas flow:5L
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chien-Chung Huang, MD
role: Study Director
affiliation: Mackay Memorial Hospital
facility: 
country: Taiwan
citation: Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.
PMID: 25625261
citation: Kneyber MC. Intraoperative mechanical ventilation for the pediatric patient. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):371-9. doi: 10.1016/j.bpa.2015.10.001. Epub 2015 Oct 14.
PMID: 26643101
citation: Glenski TA, Diehl C, Clopton RG, Friesen RH. Breathing circuit compliance and accuracy of displayed tidal volume during pressure-controlled ventilation of infants: A quality improvement project. Paediatr Anaesth. 2017 Sep;27(9):935-941. doi: 10.1111/pan.13164. Epub 2017 May 15.
PMID: 28504341
citation: von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.
PMID: 15673856
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Chien-Chung,Huang
investigator title: attending physician, department of anesthesiology
sharing ipd: No