<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/NCT04466332</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00583</org_study_id>
    <nct_id>NCT04466332</nct_id>
  </id_info>
  <brief_title>Comparison of Two ECG Guided PICC Insertion Techniques</brief_title>
  <official_title>Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne</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>
      The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted&#xD;
      Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One technique uses ECG signal transmission with saline water and allows external catheter&#xD;
      length adjustment while the other technique uses a guidewire for signal transmission thus&#xD;
      requiring prior catheter length adjustment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">August 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance from catheter tip to cavo-atrial junction (CAJ)</measure>
    <time_frame>At the end of intervention</time_frame>
    <description>At the end of intervention tip position is measured on chest fluoroscopic X-ray.&#xD;
Absolute distance in centimeters from tip to CAJ is measured on the image</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of the outgoing catheter</measure>
    <time_frame>At the end of intervention</time_frame>
    <description>Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemostasis time</measure>
    <time_frame>At the end of intervention</time_frame>
    <description>Haemostasis time at the puncture site entry point (0, 1, 3, 5, &gt;5 minutes)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Central Venous Access</condition>
  <condition>Long Term Antibiotics</condition>
  <condition>Chemotherapy</condition>
  <condition>Total Parenteral Nutrition</condition>
  <arm_group>
    <arm_group_label>Saline ECG with Pilot Tip Location System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guidewire ECG with Sherlock Tip Confirmation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LifeCath-CT PICC easy™ (Vygon)</intervention_name>
    <description>ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave.&#xD;
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein.&#xD;
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.&#xD;
The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity.&#xD;
The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).&#xD;
The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve.&#xD;
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.</description>
    <arm_group_label>Saline ECG with Pilot Tip Location System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PowerPICC-SOLO® (C.R. Bard)</intervention_name>
    <description>ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave.&#xD;
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein.&#xD;
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.&#xD;
The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside.&#xD;
The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).&#xD;
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.</description>
    <arm_group_label>Guidewire ECG with Sherlock Tip Confirmation System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
          -  Adult &gt; 18 years&#xD;
&#xD;
          -  Referred to the interventional radiology department for PICC insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected non-compliance&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
&#xD;
          -  Impairment of the heart rhythm changing the presentation of the P wave (atrial&#xD;
             fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)&#xD;
&#xD;
          -  Enrolled in conflicting research study&#xD;
&#xD;
          -  Weight&gt; 150 kg, technical limit for the fluoroscopy table&#xD;
&#xD;
          -  Impossibility of obtaining informed consent&#xD;
&#xD;
          -  Refusal to be informed in the event of a chance discovery&#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_official>
    <last_name>Salah Dine Qanadli, Prof. MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>UNIL-CHUV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUV</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne</investigator_affiliation>
    <investigator_full_name>Salah D. Qanadli, MD, PhD</investigator_full_name>
    <investigator_title>Professor MD PhD</investigator_title>
  </responsible_party>
  <keyword>PICC</keyword>
  <keyword>ECG guidance</keyword>
  <keyword>Central Venous Catheter</keyword>
  <keyword>Catheterization</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/NCT04466332
org study id: 2020-00583
nct id: NCT04466332
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted
      Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.
One technique uses ECG signal transmission with saline water and allows external catheter
      length adjustment while the other technique uses a guidewire for signal transmission thus
      requiring prior catheter length adjustment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Distance from catheter tip to cavo-atrial junction (CAJ)
time frame: At the end of intervention
description: At the end of intervention tip position is measured on chest fluoroscopic X-ray.
Absolute distance in centimeters from tip to CAJ is measured on the image
measure: Length of the outgoing catheter
time frame: At the end of intervention
description: Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters
measure: Haemostasis time
time frame: At the end of intervention
description: Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)
arm group label: Saline ECG with Pilot Tip Location System
arm group type: Experimental
description: PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water
arm group label: Guidewire ECG with Sherlock Tip Confirmation System
arm group type: Experimental
description: PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire
intervention type: Device
intervention name: LifeCath-CT PICC easy™ (Vygon)
description: ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave.
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein.
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity.
The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve.
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.
arm group label: Saline ECG with Pilot Tip Location System
intervention type: Device
intervention name: PowerPICC-SOLO® (C.R. Bard)
description: ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave.
Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein.
The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside.
The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.
arm group label: Guidewire ECG with Sherlock Tip Confirmation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salah Dine Qanadli, Prof. MD PhD
role: Study Director
affiliation: UNIL-CHUV
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne
investigator full name: Salah D. Qanadli, MD, PhD
investigator title: Professor MD PhD
sharing ipd: No