<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/NCT03782324</url>
  </required_header>
  <id_info>
    <org_study_id>CVC-MECH</org_study_id>
    <nct_id>NCT03782324</nct_id>
  </id_info>
  <brief_title>Mechanical Complications After Central Venous Catheterisation</brief_title>
  <acronym>CVC-MECH</acronym>
  <official_title>Mechanical Complications After Central Venous Catheterisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</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>
      Central venous catheters are common in modern health care and are being increasingly used in&#xD;
      both intensive care units and general wards. The primary aim of this study is to determine&#xD;
      the incidence of mechanical complications within 24 hours after central venous&#xD;
      catheterisation. The secondary aim is to identify risk factors associated with mechanical&#xD;
      complications within 24 hours after catheterisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central venous catheters provide reliable access to the bloodstream, which allows delivery of&#xD;
      medications and nutritional support that cannot be given safely through peripheral venous&#xD;
      catheters.&#xD;
&#xD;
      Mechanical complications of central venous catheterisation include bleeding (such as hematoma&#xD;
      and hemothorax), cardiac arrhythmia, arterial puncture, arterial catheterisation, nerve&#xD;
      injury, pneumothorax, failed catheterisation and catheter tip malposition. The most common&#xD;
      mechanical complications are arterial puncture, hematoma formation and pneumothorax. The&#xD;
      number of mechanical complications related to central venous catheterisation varies widely in&#xD;
      previous studies with incidences between 1.1 and 34 %. Ultrasound guidance reduces the&#xD;
      incidence of mechanical complications, but despite evidence demonstrating improved safety,&#xD;
      real-time ultrasound guidance is still not routinely used by all physicians when obtaining&#xD;
      central venous access.&#xD;
&#xD;
      Four hospitals in Region Skåne, Sweden, will participate in this study: one university&#xD;
      hospital with approximately 1300 beds and three county hospitals with about 200 beds each.&#xD;
      All central venous catheter insertions at the participating hospitals during the study period&#xD;
      will be included in the study.&#xD;
&#xD;
      The primary aim of this prospective, controlled, observational study is to determine the&#xD;
      incidence of mechanical complications within 24 hours after central venous catheterisation.&#xD;
      The secondary aim is to identify independent risk factors of mechanical complications within&#xD;
      24 hours after insertion of central venous catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cases with bleeding grade 3-4</measure>
    <time_frame>Up to 24 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Grade 3 bleedings/hematoma formation/hemothorax (bleedings requiring invasive intervention or blood transfusion) and grade 4 bleedings/hemothorax (life-threatening bleedings). Will be detected during the catheterisation or at the daily inspection by the patient responsible physician or nurse. Will be classified as major mechanical complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with bleeding grad 2</measure>
    <time_frame>Up to 24 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Grade 2 bleedings/hematoma formation (bleedings requiring external compression). Will be detected during the inserting procedure or at the daily inspection by the patient responsible physician or nurse. Will be considered minor mechanical complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with pneumothorax at post-procedural x-ray of the thorax</measure>
    <time_frame>Up to 24 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Pneumothoraces will be detected using x-ray after the central venous catheter insertion. All pneumothoraces will be classified as major mechanical complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with arterial puncture evident at the insertion procedure by the inserting physician</measure>
    <time_frame>During the procedure of inserting the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Will be detected by the inserting anesthesiologist and documented in the electronic chart. Will be considered a minor mechanical complication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with arterially positioned catheter at post-procedural x-ray</measure>
    <time_frame>Up to 24 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Will be considered a major mechanical complication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with persistent nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse</measure>
    <time_frame>Persistent more than 72 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible physician or nurse. Will be considered a major mechanical complication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse</measure>
    <time_frame>Transient up to 72 hours after insertion of the central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with arrhythmia grad 3-4 during the inserting procedure</measure>
    <time_frame>During the procedure of inserting the central venous catheter</time_frame>
    <description>Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 3 (symptomatic arrhythmia requiring urgent medical intervention) and grade 4 (symptomatic arrhythmia with life-threatening consequences) will be considered major mechanical complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with arrhythmia grad 1-2 during the inserting procedure</measure>
    <time_frame>During the procedure of inserting the central venous catheter</time_frame>
    <description>Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 1 (asymptomatic arrhythmia not requiring intervention) and grade 2 (asymptomatic or symptomatic arrhythmia requiring non-urgent medical intervention) will be considered minor mechanical complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with failure to place the catheter</measure>
    <time_frame>During the procedure of inserting the central venous catheter</time_frame>
    <description>An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Minor mechanical complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use</measure>
    <time_frame>Up to 24 hours after insertion of central venous catheter</time_frame>
    <description>Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Minor mechanical complications.</description>
  </primary_outcome>
  <enrollment type="Actual">12600</enrollment>
  <condition>Mechanical Complications of Central Venous Catheter</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients at the included hospitals who are receiving a central venous catheter&#xD;
        insertions during the study period will be observed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients receiving a central venous catheter will be observed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that dies within 24 hours after insertion of a central venous catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Kander, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skane University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Region Skåne</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03782324
org study id: CVC-MECH
nct id: NCT03782324
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central venous catheters are common in modern health care and are being increasingly used in
      both intensive care units and general wards. The primary aim of this study is to determine
      the incidence of mechanical complications within 24 hours after central venous
      catheterisation. The secondary aim is to identify risk factors associated with mechanical
      complications within 24 hours after catheterisation.
Central venous catheters provide reliable access to the bloodstream, which allows delivery of
      medications and nutritional support that cannot be given safely through peripheral venous
      catheters.

      Mechanical complications of central venous catheterisation include bleeding (such as hematoma
      and hemothorax), cardiac arrhythmia, arterial puncture, arterial catheterisation, nerve
      injury, pneumothorax, failed catheterisation and catheter tip malposition. The most common
      mechanical complications are arterial puncture, hematoma formation and pneumothorax. The
      number of mechanical complications related to central venous catheterisation varies widely in
      previous studies with incidences between 1.1 and 34 %. Ultrasound guidance reduces the
      incidence of mechanical complications, but despite evidence demonstrating improved safety,
      real-time ultrasound guidance is still not routinely used by all physicians when obtaining
      central venous access.

      Four hospitals in Region Skåne, Sweden, will participate in this study: one university
      hospital with approximately 1300 beds and three county hospitals with about 200 beds each.
      All central venous catheter insertions at the participating hospitals during the study period
      will be included in the study.

      The primary aim of this prospective, controlled, observational study is to determine the
      incidence of mechanical complications within 24 hours after central venous catheterisation.
      The secondary aim is to identify independent risk factors of mechanical complications within
      24 hours after insertion of central venous catheters.
observational model: Case-Only
time perspective: Prospective
measure: Number of cases with bleeding grade 3-4
time frame: Up to 24 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Grade 3 bleedings/hematoma formation/hemothorax (bleedings requiring invasive intervention or blood transfusion) and grade 4 bleedings/hemothorax (life-threatening bleedings). Will be detected during the catheterisation or at the daily inspection by the patient responsible physician or nurse. Will be classified as major mechanical complications
measure: Number of cases with bleeding grad 2
time frame: Up to 24 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Grade 2 bleedings/hematoma formation (bleedings requiring external compression). Will be detected during the inserting procedure or at the daily inspection by the patient responsible physician or nurse. Will be considered minor mechanical complications.
measure: Number of cases with pneumothorax at post-procedural x-ray of the thorax
time frame: Up to 24 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Pneumothoraces will be detected using x-ray after the central venous catheter insertion. All pneumothoraces will be classified as major mechanical complications
measure: Number of cases with arterial puncture evident at the insertion procedure by the inserting physician
time frame: During the procedure of inserting the central venous catheter
description: Mechanical complication after CVC-insertion. Will be detected by the inserting anesthesiologist and documented in the electronic chart. Will be considered a minor mechanical complication.
measure: Number of cases with arterially positioned catheter at post-procedural x-ray
time frame: Up to 24 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Will be considered a major mechanical complication.
measure: Number of cases with persistent nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse
time frame: Persistent more than 72 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible physician or nurse. Will be considered a major mechanical complication.
measure: Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse
time frame: Transient up to 72 hours after insertion of the central venous catheter
description: Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.
measure: Number of cases with arrhythmia grad 3-4 during the inserting procedure
time frame: During the procedure of inserting the central venous catheter
description: Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 3 (symptomatic arrhythmia requiring urgent medical intervention) and grade 4 (symptomatic arrhythmia with life-threatening consequences) will be considered major mechanical complications.
measure: Number of cases with arrhythmia grad 1-2 during the inserting procedure
time frame: During the procedure of inserting the central venous catheter
description: Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 1 (asymptomatic arrhythmia not requiring intervention) and grade 2 (asymptomatic or symptomatic arrhythmia requiring non-urgent medical intervention) will be considered minor mechanical complications.
measure: Number of cases with failure to place the catheter
time frame: During the procedure of inserting the central venous catheter
description: An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Minor mechanical complications.
measure: Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use
time frame: Up to 24 hours after insertion of central venous catheter
description: Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Minor mechanical complications.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas Kander, Ass. Prof.
role: Principal Investigator
affiliation: Skane University Hospital
facility: 
country: Sweden
responsible party type: Sponsor