xml: <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/NCT06013904</url>
    </required_header>
    <id_info>
      <org_study_id>00004870</org_study_id>
      <nct_id>NCT06013904</nct_id>
    </id_info>
    <brief_title>Difficult PIV Placement in the Pediatric ED</brief_title>
    <official_title>Can a Team of Ultrasound-Trained ED Physicians Reduce the Time to IV Placement for Children With Difficult IV Access?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas at Austin</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>
        Insertion of peripheral intravenous (PIV) lines is one of the most common procedures in the&#xD;
        Pediatric Emergency Department (ED). Faster placement of PIV lines can decrease time to&#xD;
        intervention, as well overall time patients spend in the ED. Using ultrasound (US) guidance&#xD;
        has been shown to increase the rate of first attempt success from around 50% to 78-85%&#xD;
        compared to traditional methods of placing PIVs. The Pediatric ED at DCMC has US-trained&#xD;
        nurses who assist in placing PIVs in patients with difficult access. Per ED shift, there is&#xD;
        an average of 4-6 patients that are considered difficult access. However, because of nursing&#xD;
        shortages and the general increased patient flow in the DCMC ED, there may not be a&#xD;
        US-trained nurse available when a difficult access patient needs to have a PIV placed during&#xD;
        a shift. This can lead to an increase in waiting time for the patient and delayed care.&#xD;
  &#xD;
        At the DCMC ED, if the first attempt at placing a PIV is not successful, an algorithm for a&#xD;
        level of escalation (i.e., which hospital personnel should attempt subsequent placements and&#xD;
        maximum number of attempts) is followed. Attempt at PIV placement for most patients in the ED&#xD;
        can be made by a patient care technician, RN, beside nurse, or charge nurse. If the PIV&#xD;
        placement is not successful after two tries or if the patient has known risk factors that&#xD;
        will complicate the PIV placement, the PIV placement is escalated to more experienced&#xD;
        personnel, which includes US-trained nurses. For the purposes of this protocol, we will refer&#xD;
        to these patients and personnel as Level 2 placements.&#xD;
  &#xD;
        Pediatric emergency medicine (PEM) is a clinical subspecialty that focuses on caring for&#xD;
        complicated and acutely ill pediatric patients in the emergency department. In partnership&#xD;
        with Ascension Seton Dell Children's Medical Center, UT Austin's Dell Medical School PEM&#xD;
        Fellowship is a rigorous program where Fellows are offered a broad experience in all facets&#xD;
        of pediatric emergency medicine¸ including clinical care, teaching, research, and&#xD;
        administration. A cohort of 12 Fellows are currently part of the program and could be trained&#xD;
        to administer PIV via US, being available to place PIVs in patients with difficult access&#xD;
        when a US-trained nurse is not available. We hypothesize that adding Pediatric Emergency&#xD;
        Medicine (PEM) Fellows to the rotation of personnel who can insert IVs for pediatric patients&#xD;
        with difficult access will shorten time to successful peripheral intravenous (PIV) placement&#xD;
        overall in the Dell Children's Medical Center (DCMC) Emergency Department (ED).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to placement</measure>
      <time_frame>During the patient 1 day visit, time to placement will be time from obtaining consent to successful IV placement saline flush.</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Pediatric ALL</condition>
    <arm_group>
      <arm_group_label>Usual difficult PIV placement personnel</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to this arm will follow the usual protocol for difficult IV placement (ultrasound-trained nurses) in the pediatric ED.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>US-trained PEM Fellows</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to this arm will have a trained PEM fellow place the difficult PIV in the pediatric ED.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Difficult PIV placement personnel</intervention_name>
      <description>Patients randomized to this group will have their difficult PIV placed following the usual protocol for pediatric ED patients.</description>
      <arm_group_label>Usual difficult PIV placement personnel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>US-trained PEM Fellows</intervention_name>
      <description>US-trained PEM Fellows</description>
      <arm_group_label>US-trained PEM Fellows</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 0-17&#xD;
  &#xD;
            2. Patient meets difficult/escalated PIV criteria&#xD;
  &#xD;
            3. English- or Spanish-speaking parent/guardian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Critical illness presentation, such as sepsis.&#xD;
  &#xD;
            2. Emergent medical situation, such as airway compromise, code, status epileptics, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew Wilkinson, MD, MPH</last_name>
      <role>Study Director</role>
      <affiliation>The University of Texas at Austin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lina Palomares, LMSW</last_name>
      <phone>818-207-3724</phone>
      <email>lina.palomares@austin.utexas.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
      <investigator_full_name>Lina Palomares</investigator_full_name>
      <investigator_title>Project Manager</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013904
  org study id: 00004870
  nct id: NCT06013904
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Insertion of peripheral intravenous (PIV) lines is one of the most common procedures in the
        Pediatric Emergency Department (ED). Faster placement of PIV lines can decrease time to
        intervention, as well overall time patients spend in the ED. Using ultrasound (US) guidance
        has been shown to increase the rate of first attempt success from around 50% to 78-85%
        compared to traditional methods of placing PIVs. The Pediatric ED at DCMC has US-trained
        nurses who assist in placing PIVs in patients with difficult access. Per ED shift, there is
        an average of 4-6 patients that are considered difficult access. However, because of nursing
        shortages and the general increased patient flow in the DCMC ED, there may not be a
        US-trained nurse available when a difficult access patient needs to have a PIV placed during
        a shift. This can lead to an increase in waiting time for the patient and delayed care.
  
        At the DCMC ED, if the first attempt at placing a PIV is not successful, an algorithm for a
        level of escalation (i.e., which hospital personnel should attempt subsequent placements and
        maximum number of attempts) is followed. Attempt at PIV placement for most patients in the ED
        can be made by a patient care technician, RN, beside nurse, or charge nurse. If the PIV
        placement is not successful after two tries or if the patient has known risk factors that
        will complicate the PIV placement, the PIV placement is escalated to more experienced
        personnel, which includes US-trained nurses. For the purposes of this protocol, we will refer
        to these patients and personnel as Level 2 placements.
  
        Pediatric emergency medicine (PEM) is a clinical subspecialty that focuses on caring for
        complicated and acutely ill pediatric patients in the emergency department. In partnership
        with Ascension Seton Dell Children's Medical Center, UT Austin's Dell Medical School PEM
        Fellowship is a rigorous program where Fellows are offered a broad experience in all facets
        of pediatric emergency medicine¸ including clinical care, teaching, research, and
        administration. A cohort of 12 Fellows are currently part of the program and could be trained
        to administer PIV via US, being available to place PIVs in patients with difficult access
        when a US-trained nurse is not available. We hypothesize that adding Pediatric Emergency
        Medicine (PEM) Fellows to the rotation of personnel who can insert IVs for pediatric patients
        with difficult access will shorten time to successful peripheral intravenous (PIV) placement
        overall in the Dell Children's Medical Center (DCMC) Emergency Department (ED).
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: Time to placement
  time frame: During the patient 1 day visit, time to placement will be time from obtaining consent to successful IV placement saline flush.
  arm group label: Usual difficult PIV placement personnel
  arm group type: Active Comparator
  description: Patients randomized to this arm will follow the usual protocol for difficult IV placement (ultrasound-trained nurses) in the pediatric ED.
  arm group label: US-trained PEM Fellows
  arm group type: Experimental
  description: Patients randomized to this arm will have a trained PEM fellow place the difficult PIV in the pediatric ED.
  intervention type: Procedure
  intervention name: Difficult PIV placement personnel
  description: Patients randomized to this group will have their difficult PIV placed following the usual protocol for pediatric ED patients.
  arm group label: Usual difficult PIV placement personnel
  intervention type: Procedure
  intervention name: US-trained PEM Fellows
  description: US-trained PEM Fellows
  arm group label: US-trained PEM Fellows
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew Wilkinson, MD, MPH
  role: Study Director
  affiliation: The University of Texas at Austin
  last name: Lina Palomares, LMSW
  phone: 818-207-3724
  email: lina.palomares@austin.utexas.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas at Austin
  investigator full name: Lina Palomares
  investigator title: Project Manager
  sharing ipd: No
  ipd description: IPD will not be shared.