<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/NCT04483895</url>
  </required_header>
  <id_info>
    <org_study_id>Maha Abdel-Raouf master thesis</org_study_id>
    <nct_id>NCT04483895</nct_id>
  </id_info>
  <brief_title>Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates</brief_title>
  <official_title>Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth&#xD;
      was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated&#xD;
      according to the 7-8-9 method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2019</start_date>
  <completion_date type="Anticipated">December 21, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 21, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>The OHL method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the ETT insertion depth was estimated according to the OHL method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The 7-8-9 method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the ETT insertion depth was estimated according to the 7-8-9 method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endotracheal tube insertion</intervention_name>
    <description>ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method</description>
    <arm_group_label>The 7-8-9 method</arm_group_label>
    <arm_group_label>The OHL method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Full term and preterm neonates who were admitted to NICU and needing endotracheal&#xD;
             intubation for invasive mechanical ventilation or administration of surfactant.&#xD;
&#xD;
               -  Delivery room intubations were not included as infants are not routinely weighed&#xD;
                  prior to resuscitation at our hospital. However, infants intubated in the&#xD;
                  delivery room who were subsequently intubated in the NICU were eligible for&#xD;
                  inclusion in our study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral&#xD;
        anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.&#xD;
&#xD;
        4. Neonates those whose parents declined consent were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>medicine -Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dina Mohamed, M.D.</last_name>
      <phone>+1112636097</phone>
      <email>drdodi28@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Dina Shinkar, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abeer El-Sakka, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Dina Mohamed Mohamed Shinkar</investigator_full_name>
    <investigator_title>Assistant professor of pediatrics</investigator_title>
  </responsible_party>
  <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/NCT04483895
org study id: Maha Abdel-Raouf master thesis
nct id: NCT04483895
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth
      was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated
      according to the 7-8-9 method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.
time frame: 28 days
measure: the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.
time frame: 28 days
arm group label: The OHL method
arm group type: Active Comparator
description: the ETT insertion depth was estimated according to the OHL method.
arm group label: The 7-8-9 method
arm group type: Active Comparator
description: the ETT insertion depth was estimated according to the 7-8-9 method.
intervention type: Procedure
intervention name: Endotracheal tube insertion
description: ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method
arm group label: The 7-8-9 method
arm group label: The OHL method
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Dina Mohamed Mohamed Shinkar
investigator title: Assistant professor of pediatrics
sharing ipd: Undecided