<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/NCT03778437</url>
  </required_header>
  <id_info>
    <org_study_id>2018(45)</org_study_id>
    <nct_id>NCT03778437</nct_id>
  </id_info>
  <brief_title>Facilitating Needle Alignment With Aiming Method</brief_title>
  <official_title>Aiming Method May Facilitate Needle Alignment in Ultrasound-guided Subclavian Vein Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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>
      Although ultrasound-guided catheterization of the subclavian vein is becoming standard&#xD;
      procedure in anesthetic practice, failure to align the needle and the transducer still can&#xD;
      lead to possibly complications. In this study, we proposed a new alignment method, namely&#xD;
      Aiming Method. The purpose of this study is to investigate whether the use of this aiming&#xD;
      method improved resident volunteers' performance of ultrasound-guided SC insertion in real&#xD;
      patients. Specifically, residents were asked to perform three different methods: landmark&#xD;
      techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide&#xD;
      techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural time</measure>
    <time_frame>24 hours</time_frame>
    <description>the time from skin break to guide wire was positioned into the subclavian vein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of skin breaks</measure>
    <time_frame>24 hours</time_frame>
    <description>number of skin punctures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of arterial puncture</measure>
    <time_frame>24 hours</time_frame>
    <description>aspiration of arterial blood during needle insertion or local haematoma in ultrasound image</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of pneumothorax</measure>
    <time_frame>24 hours</time_frame>
    <description>aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">474</enrollment>
  <condition>Central Venous Catheters</condition>
  <arm_group>
    <arm_group_label>landmark techniques</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subclavian vein catheterization is performed without the guidance of ultrasound. The needle was inserted 1 cm inferior and 1 cm lateral to the junction of the middle and medial thirds of the clavicle (infraclavicular approach)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ultrasound-guided with aiming method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ultrasound-guided plus needle guide techniques</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subclavian vein catheterization</intervention_name>
    <description>Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.</description>
    <arm_group_label>ultrasound-guided with aiming method</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>landmark techniques</intervention_name>
    <description>The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.</description>
    <arm_group_label>landmark techniques</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided plus needle guide techniques</intervention_name>
    <description>Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.</description>
    <arm_group_label>ultrasound-guided plus needle guide techniques</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years to 70 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Physical Status Ⅰ-Ⅲ&#xD;
&#xD;
          -  Elective surgery patients requiring subclavian vein catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Local anatomic abnormalities in subclavicular area&#xD;
&#xD;
          -  Preexisting subclavian vein thrombosis or coagulation disorders&#xD;
&#xD;
          -  Refusal of subclavian vein catheterization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Daping Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 20, 2020</last_update_submitted>
  <last_update_submitted_qc>September 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Qingxiang Mao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03778437
org study id: 2018(45)
nct id: NCT03778437
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Although ultrasound-guided catheterization of the subclavian vein is becoming standard
      procedure in anesthetic practice, failure to align the needle and the transducer still can
      lead to possibly complications. In this study, we proposed a new alignment method, namely
      Aiming Method. The purpose of this study is to investigate whether the use of this aiming
      method improved resident volunteers' performance of ultrasound-guided SC insertion in real
      patients. Specifically, residents were asked to perform three different methods: landmark
      techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide
      techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Procedural time
time frame: 24 hours
description: the time from skin break to guide wire was positioned into the subclavian vein
measure: Number of skin breaks
time frame: 24 hours
description: number of skin punctures
measure: The incidence of arterial puncture
time frame: 24 hours
description: aspiration of arterial blood during needle insertion or local haematoma in ultrasound image
measure: The incidence of pneumothorax
time frame: 24 hours
description: aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography
arm group label: landmark techniques
arm group type: Active Comparator
description: Subclavian vein catheterization is performed without the guidance of ultrasound. The needle was inserted 1 cm inferior and 1 cm lateral to the junction of the middle and medial thirds of the clavicle (infraclavicular approach)
arm group label: ultrasound-guided with aiming method
arm group type: Experimental
description: Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound.
arm group label: ultrasound-guided plus needle guide techniques
arm group type: Experimental
description: Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique.
intervention type: Procedure
intervention name: subclavian vein catheterization
description: Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.
arm group label: ultrasound-guided with aiming method
intervention type: Procedure
intervention name: landmark techniques
description: The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.
arm group label: landmark techniques
intervention type: Procedure
intervention name: Ultrasound-guided plus needle guide techniques
description: Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.
arm group label: ultrasound-guided plus needle guide techniques
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
investigator full name: Qingxiang Mao
investigator title: Principal Investigator