<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/NCT04481854</url>
  </required_header>
  <id_info>
    <org_study_id>Sellick vs paratracheal</org_study_id>
    <nct_id>NCT04481854</nct_id>
  </id_info>
  <brief_title>Cricoid Pressure Versus Paratracheal Pressure</brief_title>
  <official_title>Cricoid Pressure Versus Paratracheal Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mongi Slim Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mongi Slim 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>
      Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal&#xD;
      surgery under general anesthesia and tracheal intubation. in this study the investigators&#xD;
      will compare the classic cricoid pressure and the left paratracheal pressure regarding their&#xD;
      impact on the intubation condition and the effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal&#xD;
      surgery under general anesthesia and tracheal intubation. in this study the investigators&#xD;
      will compare the classic cricoid pressure and the left paratracheal pressure regarding their&#xD;
      impact on the intubation condition and the effectiveness.&#xD;
&#xD;
      During the laryngoscopy, the modification of the Cormack and Lehane grade before and after&#xD;
      the application of the cricoid or paratracheal pressure will be noticed.&#xD;
&#xD;
      concerning the effectiveness of the procedure, a gastric tube will be introduced through the&#xD;
      oesophagus during the procedure, under direct vision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>
    <intervention_model_description>patients will be randomized to recieve cricoid pressure or left paratracheal pressure</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modification of Cormack and Lehane grade</measure>
    <time_frame>3 minutes after induction of general anesthesia</time_frame>
    <description>Cormack and Lehane grade before and after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of the pressure</measure>
    <time_frame>5 minutes after induction of general anesthesia</time_frame>
    <description>Possibility to introduce a gastric tube through the oesophagus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cricoid Pressure During Tracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Cricoid pressure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of this group will recieve cricoid pressure during direct laryngoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>left paratracheal pressure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cricoid pressure</intervention_name>
    <description>cricoid pressure during laryngoscopy</description>
    <arm_group_label>Cricoid pressure group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>left paratracheal pressure</intervention_name>
    <description>left paratracheal pressure during laryngoscopy</description>
    <arm_group_label>left paratracheal pressure group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with no criteria of difficult intubation or mask ventilation&#xD;
&#xD;
          -  no criteria of full stomach requiring crush induction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unexpected difficult laryngoscopy or mask ventilation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mhamed Sami Mebazaa, professor</last_name>
    <phone>0021622252589</phone>
    <email>msmebazaa@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Asma Ben Souissi, Ass Prof</last_name>
    <phone>0021698336883</phone>
    <email>bsouissiasma@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mongi Slim Hospital</name>
      <address>
        <city>Tunis</city>
        <zip>2046</zip>
        <country>Tunisia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mhamed Sami Mebazaa, professor</last_name>
      <phone>0021622252589</phone>
      <email>msmebazaa@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Asma Ben Souissi, Ass Prof</last_name>
      <phone>0021698336883</phone>
      <email>bsouissiasma@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mongi Slim Hospital</investigator_affiliation>
    <investigator_full_name>Mhamed Sami Mebazaa</investigator_full_name>
    <investigator_title>Professor head of the anesthesia and intensive care department</investigator_title>
  </responsible_party>
  <keyword>cricoid pressure</keyword>
  <keyword>paratracheal pressure</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/NCT04481854
org study id: Sellick vs paratracheal
nct id: NCT04481854
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal
      surgery under general anesthesia and tracheal intubation. in this study the investigators
      will compare the classic cricoid pressure and the left paratracheal pressure regarding their
      impact on the intubation condition and the effectiveness.
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal
      surgery under general anesthesia and tracheal intubation. in this study the investigators
      will compare the classic cricoid pressure and the left paratracheal pressure regarding their
      impact on the intubation condition and the effectiveness.

      During the laryngoscopy, the modification of the Cormack and Lehane grade before and after
      the application of the cricoid or paratracheal pressure will be noticed.

      concerning the effectiveness of the procedure, a gastric tube will be introduced through the
      oesophagus during the procedure, under direct vision.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: patients will be randomized to recieve cricoid pressure or left paratracheal pressure
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Modification of Cormack and Lehane grade
time frame: 3 minutes after induction of general anesthesia
description: Cormack and Lehane grade before and after the procedure
measure: Effectiveness of the pressure
time frame: 5 minutes after induction of general anesthesia
description: Possibility to introduce a gastric tube through the oesophagus
arm group label: Cricoid pressure group
arm group type: Experimental
description: Patients of this group will recieve cricoid pressure during direct laryngoscopy.
arm group label: left paratracheal pressure group
arm group type: Experimental
description: Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.
intervention type: Procedure
intervention name: cricoid pressure
description: cricoid pressure during laryngoscopy
arm group label: Cricoid pressure group
intervention type: Procedure
intervention name: left paratracheal pressure
description: left paratracheal pressure during laryngoscopy
arm group label: left paratracheal pressure group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mhamed Sami Mebazaa, professor
phone: 0021622252589
email: msmebazaa@gmail.com
last name: Asma Ben Souissi, Ass Prof
phone: 0021698336883
email: bsouissiasma@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Tunisia
responsible party type: Principal Investigator
investigator affiliation: Mongi Slim Hospital
investigator full name: Mhamed Sami Mebazaa
investigator title: Professor head of the anesthesia and intensive care department
sharing ipd: No