<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/NCT04432701</url>
  </required_header>
  <id_info>
    <org_study_id>A/P extubation</org_study_id>
    <nct_id>NCT04432701</nct_id>
  </id_info>
  <brief_title>Extubation in Pediatric Patients: Proactive or Passive?</brief_title>
  <official_title>Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye &amp; ENT Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye &amp; ENT Hospital of Fudan University</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>
      Smooth extubation process can reduce the complications in recovery time. This study aimed to&#xD;
      investigate what is the better time to extubation when children is breathing spontaneously&#xD;
      and adequately: waiting until children have movements or wakefulness (passive extubation）or&#xD;
      removing endotracheal tube directly (proactive tracheal extubation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled cross-over trial. The hypothesis of this study is that the&#xD;
      different extubation protocol can impact recovery quality in children in post-anaesthesia&#xD;
      care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive&#xD;
      extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned&#xD;
      off and patients all delivered into PACU for recovery. Patient was positioned on his or her&#xD;
      lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the&#xD;
      patients regained spontaneous respiration. After spontaneous breathing turn to regular and&#xD;
      sufficient（tidal volume &gt;6-8 ml/kg, respiratory rate &gt;10 times per minutes , end tidal carbon&#xD;
      dioxide concentration &gt;7.19 mmHg）, the trachea tube could be removed. In Group A, patients&#xD;
      were extubated in a light plane of anesthesia, when they are still asleep or have swallowing&#xD;
      reflex. In Group B, tracheal extubation was performed when the patient regained&#xD;
      consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After&#xD;
      extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups.&#xD;
      Patients were transported to the ward until they breathed air with a patent airway. The&#xD;
      extubation time, recovery characteristics and respiratory complication were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coughing</measure>
    <time_frame>at the time of extubation within 1 minute</time_frame>
    <description>1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 &lt;95%; and 4 if multiple coughs occurred, SpO2 &lt;95%, and coughing required administration of i.v . medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>During the time when patients stayed in PACU after extubation, an average of 45 min</time_frame>
    <description>the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2&lt;90%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to spontaneous eye opening</measure>
    <time_frame>The time from PACU arrival to spontaneous eye opening, an average of 45 min</time_frame>
    <description>Time to spontaneous eye opening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to discharge from PACU</measure>
    <time_frame>The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour</time_frame>
    <description>Time to discharge from PACU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to extubation</measure>
    <time_frame>The time from PACU arrival to tracheal extubation, an average of 30 min</time_frame>
    <description>The time of extubation after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-tidal concentration of minimum effective alveolar anesthetic concentration</measure>
    <time_frame>The time before patients were decided to extubate, within 1 minute</time_frame>
    <description>In percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>6 hours before intervention</time_frame>
    <description>In years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>6 hours before intervention</time_frame>
    <description>In kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>6 hours before intervention</time_frame>
    <description>In meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>5 minutes before extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>1 minute after extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>5 minutes after extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>5 minutes before extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>1 minute after extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>5 minutes after extubation</time_frame>
    <description>Hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>5 minutes before extubation</time_frame>
    <description>hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>1 minute after extubation</time_frame>
    <description>hemodynamic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>5 minutes after extubation</time_frame>
    <description>hemodynamic parameter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cough</condition>
  <condition>Tracheal Extubation</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>proactive extubation</intervention_name>
    <description>when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly</description>
    <arm_group_label>group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status aged 3-7 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a suspected difficult airway reactive airway disease, recent upper respiratory tract&#xD;
             infection gastrointestinal reflux obesity (body mass index&gt;30 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Tsukamoto M, Hitosugi T, Yokoyama T. Comparison of recovery in pediatric patients: a retrospective study. Clin Oral Investig. 2019 Sep;23(9):3653-3656. doi: 10.1007/s00784-019-02993-y. Epub 2019 Jul 4.</citation>
    <PMID>31273527</PMID>
  </reference>
  <reference>
    <citation>Bidwai AV, Bidwai VA, Rogers CR, Stanley TH. Blood-pressure and pulse-rate responses to endotracheal extubation with and without prior injection of lidocaine. Anesthesiology. 1979 Aug;51(2):171-3. doi: 10.1097/00000542-197908000-00020. No abstract available.</citation>
    <PMID>453622</PMID>
  </reference>
  <reference>
    <citation>Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16.</citation>
    <PMID>12707126</PMID>
  </reference>
  <results_reference>
    <citation>Gonzalez RM, Bjerke RJ, Drobycki T, Stapelfeldt WH, Green JM, Janowitz MJ, Clark M. Prevention of endotracheal tube-induced coughing during emergence from general anesthesia. Anesth Analg. 1994 Oct;79(4):792-5. doi: 10.1213/00000539-199410000-00030. No abstract available.</citation>
    <PMID>7943794</PMID>
  </results_reference>
  <results_reference>
    <citation>Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7.</citation>
    <PMID>26202786</PMID>
  </results_reference>
  <results_reference>
    <citation>Inomata S, Yaguchi Y, Taguchi M, Toyooka H. End-tidal sevoflurane concentration for tracheal extubation (MACEX) in adults: comparison with isoflurane. Br J Anaesth. 1999 Jun;82(6):852-6. doi: 10.1093/bja/82.6.852.</citation>
    <PMID>10562778</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 28, 2023</last_update_submitted>
  <last_update_submitted_qc>January 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>passive</keyword>
  <keyword>proactive</keyword>
  <keyword>extubation</keyword>
  <keyword>respiratory complication</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/NCT04432701
org study id: A/P extubation
nct id: NCT04432701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Smooth extubation process can reduce the complications in recovery time. This study aimed to
      investigate what is the better time to extubation when children is breathing spontaneously
      and adequately: waiting until children have movements or wakefulness (passive extubation）or
      removing endotracheal tube directly (proactive tracheal extubation).
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the
      different extubation protocol can impact recovery quality in children in post-anaesthesia
      care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive
      extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned
      off and patients all delivered into PACU for recovery. Patient was positioned on his or her
      lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the
      patients regained spontaneous respiration. After spontaneous breathing turn to regular and
      sufficient（tidal volume >6-8 ml/kg, respiratory rate >10 times per minutes , end tidal carbon
      dioxide concentration >7.19 mmHg）, the trachea tube could be removed. In Group A, patients
      were extubated in a light plane of anesthesia, when they are still asleep or have swallowing
      reflex. In Group B, tracheal extubation was performed when the patient regained
      consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After
      extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups.
      Patients were transported to the ward until they breathed air with a patent airway. The
      extubation time, recovery characteristics and respiratory complication were recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Coughing
time frame: at the time of extubation within 1 minute
description: 1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 <95%; and 4 if multiple coughs occurred, SpO2 <95%, and coughing required administration of i.v . medication.
measure: Respiratory complications
time frame: During the time when patients stayed in PACU after extubation, an average of 45 min
description: the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2<90%
measure: Time to spontaneous eye opening
time frame: The time from PACU arrival to spontaneous eye opening, an average of 45 min
description: Time to spontaneous eye opening
measure: Time to discharge from PACU
time frame: The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour
description: Time to discharge from PACU
measure: Time to extubation
time frame: The time from PACU arrival to tracheal extubation, an average of 30 min
description: The time of extubation after surgery
measure: End-tidal concentration of minimum effective alveolar anesthetic concentration
time frame: The time before patients were decided to extubate, within 1 minute
description: In percentage
measure: Age
time frame: 6 hours before intervention
description: In years
measure: Weight
time frame: 6 hours before intervention
description: In kilograms
measure: Height
time frame: 6 hours before intervention
description: In meters
measure: Systolic blood pressure
time frame: 5 minutes before extubation
description: Hemodynamic parameter
measure: Systolic blood pressure
time frame: 1 minute after extubation
description: Hemodynamic parameter
measure: Systolic blood pressure
time frame: 5 minutes after extubation
description: Hemodynamic parameter
measure: Diastolic blood pressure
time frame: 5 minutes before extubation
description: Hemodynamic parameter
measure: Diastolic blood pressure
time frame: 1 minute after extubation
description: Hemodynamic parameter
measure: Diastolic blood pressure
time frame: 5 minutes after extubation
description: Hemodynamic parameter
measure: Heart rate
time frame: 5 minutes before extubation
description: hemodynamic parameter
measure: Heart rate
time frame: 1 minute after extubation
description: hemodynamic parameter
measure: Heart rate
time frame: 5 minutes after extubation
description: hemodynamic parameter
arm group label: group A
arm group type: Active Comparator
description: children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.
arm group label: group B
arm group type: No Intervention
description: Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.
intervention type: Behavioral
intervention name: proactive extubation
description: when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly
arm group label: group A
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
facility: 
country: China
citation: Tsukamoto M, Hitosugi T, Yokoyama T. Comparison of recovery in pediatric patients: a retrospective study. Clin Oral Investig. 2019 Sep;23(9):3653-3656. doi: 10.1007/s00784-019-02993-y. Epub 2019 Jul 4.
PMID: 31273527
citation: Bidwai AV, Bidwai VA, Rogers CR, Stanley TH. Blood-pressure and pulse-rate responses to endotracheal extubation with and without prior injection of lidocaine. Anesthesiology. 1979 Aug;51(2):171-3. doi: 10.1097/00000542-197908000-00020. No abstract available.
PMID: 453622
citation: Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16.
PMID: 12707126
citation: Gonzalez RM, Bjerke RJ, Drobycki T, Stapelfeldt WH, Green JM, Janowitz MJ, Clark M. Prevention of endotracheal tube-induced coughing during emergence from general anesthesia. Anesth Analg. 1994 Oct;79(4):792-5. doi: 10.1213/00000539-199410000-00030. No abstract available.
PMID: 7943794
citation: Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7.
PMID: 26202786
citation: Inomata S, Yaguchi Y, Taguchi M, Toyooka H. End-tidal sevoflurane concentration for tracheal extubation (MACEX) in adults: comparison with isoflurane. Br J Anaesth. 1999 Jun;82(6):852-6. doi: 10.1093/bja/82.6.852.
PMID: 10562778
responsible party type: Sponsor
sharing ipd: No