<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/NCT04414839</url>
  </required_header>
  <id_info>
    <org_study_id>397585</org_study_id>
    <nct_id>NCT04414839</nct_id>
  </id_info>
  <brief_title>Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy</brief_title>
  <acronym>NGT</acronym>
  <official_title>Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</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>
      Abstract Background: A number of patients referring to the emergency departments (EDs) due to&#xD;
      airway obstruction or decreased level of consciousness require the establishment of a&#xD;
      definite airway using intubation. On the other hand, performing Nasogastric tube (NGT)&#xD;
      insertion is very challenging in anesthetized and intubated patients. And, a conclusive&#xD;
      method has not yet been presented in this regard. Hence, the current study aimed at comparing&#xD;
      Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.&#xD;
&#xD;
      Materials and Methods: The present clinical trial was performed on 76 intubated patients that&#xD;
      were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and&#xD;
      Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of&#xD;
      attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients'&#xD;
      satisfaction level were recorded and examined in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 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>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate</measure>
    <time_frame>Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)</time_frame>
    <description>being successfully inserted into the stomach</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion duration</measure>
    <time_frame>Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)</time_frame>
    <description>Measuring how long will it last to insert successfully an NG tube into the stomach</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Intubated Patients</condition>
  <arm_group>
    <arm_group_label>Digital Intubation (Two-finger)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Digital Intubation (Two-finger)</intervention_name>
    <description>In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.</description>
    <arm_group_label>Digital Intubation (Two-finger)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Video Laryngoscopy</intervention_name>
    <description>In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.</description>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 year old patients that underwent rapid sequence intubation (RSI) and required&#xD;
             NGT insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having skull base fracture symptoms&#xD;
&#xD;
          -  coagulopathy and hemorrhagic disorders&#xD;
&#xD;
          -  maxillofacial traumas leading to the deformity and disturbance in NGT insertion&#xD;
&#xD;
          -  diseases and anomalies of the upper respiratory tract&#xD;
&#xD;
          -  deviated nasal septum&#xD;
&#xD;
          -  nostril stenosis&#xD;
&#xD;
          -  esophageal disorders (esophageal stricture, esophageal varices)&#xD;
&#xD;
          -  a history of head and neck radiotherapy, and&#xD;
&#xD;
          -  patients intubated in and transferred from other centers&#xD;
&#xD;
          -  patients with more than two unsuccessful attempts at NGT insertion were excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Al-Zahra University Hospital</name>
      <address>
        <city>Isfahan</city>
        <zip>8138938728</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mehdi Nasr Isfahani</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Digital Laryngoscopy</keyword>
  <keyword>Endotracheal Tube</keyword>
  <keyword>Nasogastric Tube (NGT)</keyword>
  <keyword>Video Laryngoscopy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>if requested, it will be shared formally by email to the journal office.</ipd_description>
  </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/NCT04414839
org study id: 397585
nct id: NCT04414839
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Abstract Background: A number of patients referring to the emergency departments (EDs) due to
      airway obstruction or decreased level of consciousness require the establishment of a
      definite airway using intubation. On the other hand, performing Nasogastric tube (NGT)
      insertion is very challenging in anesthetized and intubated patients. And, a conclusive
      method has not yet been presented in this regard. Hence, the current study aimed at comparing
      Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.

      Materials and Methods: The present clinical trial was performed on 76 intubated patients that
      were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and
      Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of
      attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients'
      satisfaction level were recorded and examined in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Investigator)
measure: Success rate
time frame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
description: being successfully inserted into the stomach
measure: Insertion duration
time frame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
description: Measuring how long will it last to insert successfully an NG tube into the stomach
arm group label: Digital Intubation (Two-finger)
arm group type: Active Comparator
arm group label: Video Laryngoscopy
arm group type: Active Comparator
intervention type: Device
intervention name: Digital Intubation (Two-finger)
description: In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.
arm group label: Digital Intubation (Two-finger)
intervention type: Device
intervention name: Video Laryngoscopy
description: In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.
arm group label: Video Laryngoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Mehdi Nasr Isfahani
investigator title: Dr.
sharing ipd: Undecided
ipd description: if requested, it will be shared formally by email to the journal office.