<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/NCT03006640</url>
  </required_header>
  <id_info>
    <org_study_id>Refa-NTG-art</org_study_id>
    <nct_id>NCT03006640</nct_id>
  </id_info>
  <brief_title>Subcutaneous NTG for US Radial Artery Cannulation</brief_title>
  <acronym>NTG-US-art</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>AlRefaey Kandeel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,&#xD;
      difficult sampling and problems encountered with noninvasive blood pressure monitoring makes&#xD;
      arterial cannulation an essential skill in many situations like surgeries or trans-radial&#xD;
      procedures for coronary or carotid interventions.&#xD;
&#xD;
      Radial artery has been preferred over other sites for arterial cannulation due to low&#xD;
      incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this&#xD;
      study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming&#xD;
      to decrease insertion time, increase success rate and decrease related complications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate</measure>
    <time_frame>24 hours after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NTG group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subcutaneous nitroglycrin</intervention_name>
    <description>In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline</description>
    <arm_group_label>NTG group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subcutaneous saline</intervention_name>
    <description>In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  morbid obese indicated for radial artery cannuulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  +ve allen test peripheral arterial disease refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>AlRefaey Kandeel</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <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/NCT03006640
org study id: Refa-NTG-art
nct id: NCT03006640
lead sponsor: 
has dmc: Yes
Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,
      difficult sampling and problems encountered with noninvasive blood pressure monitoring makes
      arterial cannulation an essential skill in many situations like surgeries or trans-radial
      procedures for coronary or carotid interventions.

      Radial artery has been preferred over other sites for arterial cannulation due to low
      incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this
      study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming
      to decrease insertion time, increase success rate and decrease related complications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Success rate
time frame: 24 hours after surgery
arm group label: Control group
arm group type: Placebo Comparator
arm group label: NTG group
arm group type: Active Comparator
intervention type: Drug
intervention name: Subcutaneous nitroglycrin
description: In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
arm group label: NTG group
intervention type: Drug
intervention name: Subcutaneous saline
description: In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: AlRefaey Kandeel
investigator title: Dr
mesh term: Obesity, Morbid
sharing ipd: Undecided