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CompletedNCT03954977PUPUpdated Sep 26, 2019

Point of Care Ultrasound for PICC Line Monitoring Study

An interventional study of PICC line ultrasound in Peripherally Inserted Central Catheters, sponsored by Seattle Children's Hospital. Completed at 2 sites in United States. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was Aug 2019, 7 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
Up to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripherally Inserted Central Catheters

Keywords

  • PICC line
  • Neonate
03

In context

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 214 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • vertebral anomalies
  • anomalies of venous anatomy
  • tracheal anomalies.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testPICC 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.

06

What researchers measure

Primary outcomes

  1. PICC line tip is located by the ultrasound operator

    PICC line identified under ultrasound

    Time frame: 6 months

Secondary outcomes

  1. PICC line location on ultrasound agrees with radiograph

    PICC line localization on ultrasound is the same as the localization of the PICC line on radiograph

    Time frame: 6 months

07

Study locations

2 sites
  • Seattle Childrens Hospital
    Seattle, Washington 98105, United States
  • University Of Washington
    Seattle, Washington 98195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2019 to primary completion in Aug 2019, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2019
First posted
May 17, 2019
StartActual
Feb 10, 2019
Primary completionActual
Aug 30, 2019
CompletionActual
Aug 30, 2019
Last update
Sep 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03954977
Responsible party
Patrick Motz (Neonatal Perinatal Fellow, Seattle Children's Hospital) — Principal investigator
First posted
May 17, 2019
Start date
Feb 10, 2019
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Sep 26, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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