Point of Care Ultrasound for PICC Line Monitoring Study

Peripherally Inserted Central Catheters Clinical Trial

— PUP  

Official title:

Point of Care Ultrasound for PICC Line Monitoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954977
• Other study ID #: 0503
• Status: Completed
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Peripherally Inserted Central Catheters

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Childrens Hospital	Seattle	Washington
United States	University Of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PICC line tip is located by the ultrasound operator	PICC line identified under ultrasound	6 months
Secondary	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