<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/NCT04444479</url>
  </required_header>
  <id_info>
    <org_study_id>PICC-07-ECG_Navigation</org_study_id>
    <secondary_id>07/ RVO- FNOs/ 2020</secondary_id>
    <secondary_id>MH CZ - DRO - FNOs/2020</secondary_id>
    <nct_id>NCT04444479</nct_id>
  </id_info>
  <brief_title>Insertion of PICC With Intracavitary ECG Navigation</brief_title>
  <official_title>PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</source>
  <oversight_info>
    <has_dmc>No</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 study subjects who are indicated for peripherally inserted central (PICC) catheter&#xD;
      placement will undergo this procedure under the control of ECG, the correct position of the&#xD;
      PICC catheter tip will be subsequently verified X-ray imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study subjects who are indicated for PICC catheter placement will undergo this procedure&#xD;
      under the control of electrocardiography (ECG), the correct position of the PICC catheter tip&#xD;
      will be subsequently verified X-ray imaging.&#xD;
&#xD;
      Conducting this study should allow us to see the feasibility of using real-time ECG&#xD;
      navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to&#xD;
      eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both&#xD;
      methods will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking will be used in the study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time interval between ECG and X-ray</measure>
    <time_frame>2 hours</time_frame>
    <description>The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success-rate of correct PICC tip location</measure>
    <time_frame>2 hours</time_frame>
    <description>The success-rate of correct PICC tip location will be determined using ECG navigation against the use of chest X-ray, and expressed as distance in centimetres from the target point.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Long-term Venous Access</condition>
  <arm_group>
    <arm_group_label>PICC catheter placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects in whom placement of the PICC catheter is indicated</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ECG verification</intervention_name>
    <description>The correct positioning of the PICC catheter tip will be verified using ECG.</description>
    <arm_group_label>PICC catheter placement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>X-ray verification</intervention_name>
    <description>The correct positioning of the PICC catheter tip will be verified using X-ray imaging.</description>
    <arm_group_label>PICC catheter placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for establishing long-term venous access&#xD;
&#xD;
          -  18 years of age and over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  oncological patients&#xD;
&#xD;
          -  non-signing the informed consent form&#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>Iveta Constantine, Bc.,MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Moravian-Silesian Region</state>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.</citation>
    <PMID>21667458</PMID>
  </reference>
  <reference>
    <citation>Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.</citation>
    <PMID>27231736</PMID>
  </reference>
  <reference>
    <citation>Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.</citation>
    <PMID>25040430</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>peripherally inserted central catheter</keyword>
  <keyword>ECG navigation</keyword>
  <keyword>chest x-ray</keyword>
  <keyword>PICC tip navigation</keyword>
  <keyword>catheter tip location</keyword>
  <keyword>intracavitary ECG</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers. The data may be provided upon request.</ipd_description>
  </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/NCT04444479
org study id: PICC-07-ECG_Navigation
secondary id: 07/ RVO- FNOs/ 2020
secondary id: MH CZ - DRO - FNOs/2020
nct id: NCT04444479
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study subjects who are indicated for peripherally inserted central (PICC) catheter
      placement will undergo this procedure under the control of ECG, the correct position of the
      PICC catheter tip will be subsequently verified X-ray imaging.
The study subjects who are indicated for PICC catheter placement will undergo this procedure
      under the control of electrocardiography (ECG), the correct position of the PICC catheter tip
      will be subsequently verified X-ray imaging.

      Conducting this study should allow us to see the feasibility of using real-time ECG
      navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to
      eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both
      methods will be assessed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
primary purpose: Other
masking: None (Open Label)
masking description: No masking will be used in the study
measure: Time interval between ECG and X-ray
time frame: 2 hours
description: The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.
measure: Success-rate of correct PICC tip location
time frame: 2 hours
description: The success-rate of correct PICC tip location will be determined using ECG navigation against the use of chest X-ray, and expressed as distance in centimetres from the target point.
arm group label: PICC catheter placement
arm group type: Experimental
description: Study subjects in whom placement of the PICC catheter is indicated
intervention type: Other
intervention name: ECG verification
description: The correct positioning of the PICC catheter tip will be verified using ECG.
arm group label: PICC catheter placement
intervention type: Other
intervention name: X-ray verification
description: The correct positioning of the PICC catheter tip will be verified using X-ray imaging.
arm group label: PICC catheter placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iveta Constantine, Bc.,MSc.
role: Principal Investigator
affiliation: University Hospital Ostrava
facility: 
country: Czechia
citation: Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.
PMID: 21667458
citation: Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.
PMID: 27231736
citation: Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.
PMID: 25040430
responsible party type: Sponsor
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.