<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/NCT03778762</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.11.129</org_study_id>
    <nct_id>NCT03778762</nct_id>
  </id_info>
  <brief_title>Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway</brief_title>
  <official_title>Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the success rate of blind technique with correction manoeuvres versus fiber optic-&#xD;
      guided Intubation through the air Q laryngeal airway in pediatric patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prior G-power analysis was done to estimate the sample size. The primary outcome of this&#xD;
      study was the first trial success rate. Using fibre exact test and assuming alpha (type I&#xD;
      error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be&#xD;
      sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of&#xD;
      cases was expected; therefore 63 patients were required in each group to detect the&#xD;
      difference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The first trial success rate</measure>
    <time_frame>during first trial of intubation procedure</time_frame>
    <description>percentage of cases of successful tracheal intubation during the first trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total success rate</measure>
    <time_frame>from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure</time_frame>
    <description>percentage of cases underwent successful tracheal intubation during either first or second trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to ventilation</measure>
    <time_frame>procedure (Time from beginning of air-Q insertion till full capno-graphic wave)</time_frame>
    <description>time needed to get full capno-graphic waves through connection of air Q to breathing circuit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to intubation</measure>
    <time_frame>procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)</time_frame>
    <description>time needed to get full capno-graphic waves through connection of endotracheal tube to breathing circuit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>After induction of anesthesia till 10 minutes after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>After induction of anesthesia till 10 minutes after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood staining of the device</measure>
    <time_frame>from extubation till 24 hours after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-intubation croup</measure>
    <time_frame>from extubation till 24 hours after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hoarsenes</measure>
    <time_frame>from extubation till 24 hours after extubation</time_frame>
    <description>and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Techniques of Endotracheal Intubation in Pediatrics</condition>
  <arm_group>
    <arm_group_label>Blind tracheal intubation through AirQ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were intubated through the air-Q blindly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiberscopic tracheal intubation through AirQ</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients were intubated through the air-Q using fibreoptic bronchoscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blind tracheal intubation through AirQ</intervention_name>
    <description>underwent blind intubation with correction manoeuvres</description>
    <arm_group_label>Blind tracheal intubation through AirQ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fiberscopic tracheal intubation through AirQ</intervention_name>
    <description>: underwent fibreoptic guided intubation</description>
    <arm_group_label>Fiberscopic tracheal intubation through AirQ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I-II&#xD;
&#xD;
          -  Body weight from 4 to 30 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  History of gastroesophageal reflux&#xD;
&#xD;
          -  History of hyperactive airway&#xD;
&#xD;
          -  Patients with congenital disorders associated with difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enas A Abd el Motlb, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Enas A Abd el Motlb</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03778762
org study id: R/17.11.129
nct id: NCT03778762
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the success rate of blind technique with correction manoeuvres versus fiber optic-
      guided Intubation through the air Q laryngeal airway in pediatric patients
A prior G-power analysis was done to estimate the sample size. The primary outcome of this
      study was the first trial success rate. Using fibre exact test and assuming alpha (type I
      error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be
      sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of
      cases was expected; therefore 63 patients were required in each group to detect the
      difference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The first trial success rate
time frame: during first trial of intubation procedure
description: percentage of cases of successful tracheal intubation during the first trial
measure: The total success rate
time frame: from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure
description: percentage of cases underwent successful tracheal intubation during either first or second trial
measure: Time to ventilation
time frame: procedure (Time from beginning of air-Q insertion till full capno-graphic wave)
description: time needed to get full capno-graphic waves through connection of air Q to breathing circuit
measure: Time to intubation
time frame: procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)
description: time needed to get full capno-graphic waves through connection of endotracheal tube to breathing circuit
measure: Heart rate
time frame: After induction of anesthesia till 10 minutes after intubation
measure: Mean arterial blood pressure
time frame: After induction of anesthesia till 10 minutes after intubation
measure: blood staining of the device
time frame: from extubation till 24 hours after extubation
measure: post-intubation croup
time frame: from extubation till 24 hours after extubation
measure: hoarsenes
time frame: from extubation till 24 hours after extubation
description: and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)
arm group label: Blind tracheal intubation through AirQ
arm group type: Active Comparator
description: Patients were intubated through the air-Q blindly
arm group label: Fiberscopic tracheal intubation through AirQ
arm group type: Placebo Comparator
description: Patients were intubated through the air-Q using fibreoptic bronchoscope
intervention type: Procedure
intervention name: Blind tracheal intubation through AirQ
description: underwent blind intubation with correction manoeuvres
arm group label: Blind tracheal intubation through AirQ
intervention type: Procedure
intervention name: Fiberscopic tracheal intubation through AirQ
description: : underwent fibreoptic guided intubation
arm group label: Fiberscopic tracheal intubation through AirQ
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Enas A Abd el Motlb, MD
role: Study Chair
affiliation: Associate Professor
facility: 
country: Egypt
responsible party type: Sponsor
sharing ipd: Undecided