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Point of Care Ultrasound for PICC Line Monitoring Study (PUP)

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ClinicalTrials.gov Identifier: NCT03954977
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Patrick Motz, Seattle Children's Hospital

Brief Summary:
A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.

Condition or disease Intervention/treatment Phase
Peripherally Inserted Central Catheters Diagnostic Test: PICC line ultrasound Not Applicable

Detailed Description:

Point of care (POC) ultrasound has become an invaluable tool for critically ill children. Several studies have been completed detailing its use for central line access and determining the location of the tip of umbilical venous lines. There are no current studies on monitoring PICC line tip placement using POC ultrasound. There have been studies showing ultrasound can be used to locate PICC line tip location, but none for monitoring. A previous study found that the sensitivity and specificity of US in identifying the location of PICC line tip were 86% and 75% respectively.

Review of the literature notes that Costa et al also found a high rate of PICC line complications. Costa et al and the investigators local experience also highlight the rare but potentially fatal complication of pericardial effusion from PICC lines that are too deep in the heart. One way the investigators could improve the safety of neonatal PICC lines is monitor them more closely. Current standard of care is to monitor PICC line tips on chest x-ray. Unfortunately, there is strong evidence that chest x-ray does not accurately identify the PICC line tip location. Another way would be to use POC ultrasound. A literature review on POC ultrasound to determine the location of a PICC line tip revealed that no such study has been done. Several studies have been completed demonstrating POC ultrasound both improved success rate and time to confirmation of placement of PICC lines.3 Pulickal et al published data on teaching pediatric residents to do point of care ultrasound to determine the location of the UVC tip. The investigators in that study found the residents were not only better at determining the correct location than chest x-ray, but the procedure was well tolerated. The investigators for this study feel further evaluation of POC ultrasound for PICC line tip monitoring to determine feasibility and accuracy is needed.

Eligible patients will be identified by the NICU care team. Participants will then be consented for the study by the study team. Trained Neonatology Fellows/Attendings will perform POC ultrasound to identify and document the PICC tip location and will be blinded to the PICC line tip location on x-ray. Ultrasounds will only be performed during patient's care times and be limited to 15 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
Masking: None (Open Label)
Masking Description: Investigator is blinded to xray result before doing ultrasound
Primary Purpose: Screening
Official Title: Point of Care Ultrasound for PICC Line Monitoring Study
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound X-Rays

Arm Intervention/treatment
Experimental: Ultrasound vs Radiograph
NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
Diagnostic Test: PICC line ultrasound
NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.




Primary Outcome Measures :
  1. PICC line tip is located by the ultrasound operator [ Time Frame: 6 months ]
    PICC line identified under ultrasound


Secondary Outcome Measures :
  1. PICC line location on ultrasound agrees with radiograph [ Time Frame: 6 months ]
    PICC line localization on ultrasound is the same as the localization of the PICC line on radiograph



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NICU patient at Seattle Childrens Hospital or University of Washington
  • Patient has a PICC line in place

Exclusion Criteria:

  • vertebral anomalies
  • anomalies of venous anatomy
  • tracheal anomalies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954977


Contacts
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Contact: Patrick Motz 206.543.3675 motzp2@uw.edu

Locations
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United States, Washington
Seattle Childrens Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Patrick Motz, DO    206-543-3675    motzp2@uw.edu   
University Of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Patrick Motz, DO    206-543-3675    motzp2@uw.edu   
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington

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Responsible Party: Patrick Motz, Neonatal Perinatal Fellow, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03954977     History of Changes
Other Study ID Numbers: 0503
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Patrick Motz, Seattle Children's Hospital:
PICC line
Neonate