<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/NCT02183857</url>
  </required_header>
  <id_info>
    <org_study_id>ANES.SS.12</org_study_id>
    <nct_id>NCT02183857</nct_id>
  </id_info>
  <brief_title>Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery</brief_title>
  <official_title>Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of ultrasound guidance by senior residents learning the technique of femoral artery&#xD;
      catheterization is superior to the landmark technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The insertion of percutaneous femoral catheter is the method of choice for arterial&#xD;
      monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut&#xD;
      Medical Center. It is easier to access since it is a bigger vessel and matches better the&#xD;
      aortic pressure immediately post initiation of bypass than the radial artery. Utilizing&#xD;
      ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4&#xD;
      trials showed that, ultrasound guidance for radial artery catheterization improved first-pass&#xD;
      success rate compared to the palpation method (2). Two of these trials were for pediatric&#xD;
      patients where in one study ultrasound-guided radial arterial cannulation in 30 small&#xD;
      children improved success rate with fewer attempts required with the ultrasound technique&#xD;
      than with the traditional technique (3). However, in another study of 152 children under 12&#xD;
      years of age requiring radial artery cannulation, there were no statistically significant&#xD;
      differences between the groups in time to successful cannulation, total number of attempts,&#xD;
      number of successful cannulations during the first attempt, or in the number of cannulae used&#xD;
      for catheterization (4). No previous study compared the use of ultrasound guidance vs&#xD;
      landmark for femoral artery cannulation in the pediatric age group in particular for the&#xD;
      teaching of anesthesia residents.&#xD;
&#xD;
      The hypothesis is that the use of ultrasound guidance by senior residents learning the&#xD;
      technique of femoral artery catheterization is superior to the landmark technique.&#xD;
&#xD;
      The investigators will design a prospective randomized trial to compare the use of ultrasound&#xD;
      guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion&#xD;
      criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or&#xD;
      infections at the potential site of insertion, need for emergency surgery, and hemodynamic&#xD;
      instability.&#xD;
&#xD;
      The risks to subjects include no more than the usual risks of arterial cannulation (infection&#xD;
      and hematoma formation). Adverse events will be monitored, reported and treated&#xD;
      appropriately.&#xD;
&#xD;
      Privacy and confidentiality will be respected. Data will be kept under lock with the primary&#xD;
      investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the time needed to achieve a successful cannulation of the femoral artery.</measure>
    <time_frame>The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in group Ultrasound will have their femoral arterial lines inserted under the guidance of US. The Ultrasound equipment used is a SonoSite 180 PLUS with an L25/10- to 5-MHz linear array transducer (SonoSite, Inc., Bothell, WA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Landmark</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No Device is used. Patients in group Landmark will have their femoral line inserted using the blinded, external landmark-guided technique. After localization of the femoral artery by identifying the pulse in the femoral triangle immediately distal to the inguinal ligament.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Ultrasound</arm_group_label>
    <other_name>SonoSite 180 PLUS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Landmark</intervention_name>
    <arm_group_label>Landmark</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infants and children under 12 years of age.&#xD;
&#xD;
          2. American Society of Anesthesiologist Physical Status (ASA) III or IV.&#xD;
&#xD;
          3. Patients with congenital heart disease undergoing cardiac surgery who do not have&#xD;
             existing arterial line access.&#xD;
&#xD;
          4. Parents/guardians/patients willing to sign consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hematoma or infections at the potential site of insertion.&#xD;
&#xD;
          2. Inability or unwillingness of research participant or legal guardian/representative to&#xD;
             give written informed consent.&#xD;
&#xD;
          3. Need for emergency surgery.&#xD;
&#xD;
          4. Hemodynamic instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sahar M Siddik-Sayyid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUBMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American University of Beirut Medical center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University of Beirut Medical Center</investigator_affiliation>
    <investigator_full_name>Sahar Sayyid</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>congenital heart disease</keyword>
  <!-- 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/NCT02183857
org study id: ANES.SS.12
nct id: NCT02183857
lead sponsor: 
has dmc: No
The use of ultrasound guidance by senior residents learning the technique of femoral artery
      catheterization is superior to the landmark technique.
The insertion of percutaneous femoral catheter is the method of choice for arterial
      monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut
      Medical Center. It is easier to access since it is a bigger vessel and matches better the
      aortic pressure immediately post initiation of bypass than the radial artery. Utilizing
      ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4
      trials showed that, ultrasound guidance for radial artery catheterization improved first-pass
      success rate compared to the palpation method (2). Two of these trials were for pediatric
      patients where in one study ultrasound-guided radial arterial cannulation in 30 small
      children improved success rate with fewer attempts required with the ultrasound technique
      than with the traditional technique (3). However, in another study of 152 children under 12
      years of age requiring radial artery cannulation, there were no statistically significant
      differences between the groups in time to successful cannulation, total number of attempts,
      number of successful cannulations during the first attempt, or in the number of cannulae used
      for catheterization (4). No previous study compared the use of ultrasound guidance vs
      landmark for femoral artery cannulation in the pediatric age group in particular for the
      teaching of anesthesia residents.

      The hypothesis is that the use of ultrasound guidance by senior residents learning the
      technique of femoral artery catheterization is superior to the landmark technique.

      The investigators will design a prospective randomized trial to compare the use of ultrasound
      guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion
      criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or
      infections at the potential site of insertion, need for emergency surgery, and hemodynamic
      instability.

      The risks to subjects include no more than the usual risks of arterial cannulation (infection
      and hematoma formation). Adverse events will be monitored, reported and treated
      appropriately.

      Privacy and confidentiality will be respected. Data will be kept under lock with the primary
      investigator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: the time needed to achieve a successful cannulation of the femoral artery.
time frame: The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer
arm group label: Ultrasound
arm group type: Other
description: Patients in group Ultrasound will have their femoral arterial lines inserted under the guidance of US. The Ultrasound equipment used is a SonoSite 180 PLUS with an L25/10- to 5-MHz linear array transducer (SonoSite, Inc., Bothell, WA)
arm group label: Landmark
arm group type: Other
description: No Device is used. Patients in group Landmark will have their femoral line inserted using the blinded, external landmark-guided technique. After localization of the femoral artery by identifying the pulse in the femoral triangle immediately distal to the inguinal ligament.
intervention type: Device
intervention name: Ultrasound
arm group label: Ultrasound
other name: SonoSite 180 PLUS
intervention type: Other
intervention name: Landmark
arm group label: Landmark
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: No
last name: Sahar M Siddik-Sayyid, MD
role: Principal Investigator
affiliation: AUBMC
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: American University of Beirut Medical Center
investigator full name: Sahar Sayyid
investigator title: Professor