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
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.
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.
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.
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.
Exclusion Criteria:
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.
PICC line tip is located by the ultrasound operator
PICC line identified under ultrasound
Time frame: 6 months
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
Plan to share: No
No publications or documents are linked to this record.
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.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.