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

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.

Study Overview

• Status: Completed
• Conditions: Peripherally Inserted Central Catheters
• Intervention / Treatment: Diagnostic test: PICC line ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98105
      • Seattle Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PICC line tip is located by the ultrasound operator	PICC line identified under ultrasound	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: April 28, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Neonate; PICC line
• Other Study ID Numbers: 0503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes