Point of Care Ultrasound for PICC Line Monitoring Study

NCT03954977 | Completed DMC FDA Device

• 1 other identifier: 0503
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripherally Inserted Central Catheters

Keywords

PICC line; Neonate

Outcome Measures

Primary Outcomes (1)

• PICC line tip is located by the ultrasound operator

  PICC line identified under ultrasound

  6 months

Secondary Outcomes (1)

• PICC line location on ultrasound agrees with radiograph

  6 months

Study Arms (1)

Ultrasound vs Radiograph

EXPERIMENTAL

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

PICC line ultrasound DIAGNOSTIC_TEST

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.

Ultrasound vs Radiograph

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (2)

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

Location

University Of Washington

Seattle, Washington, 98195, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator is blinded to xray result before doing ultrasound
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal Perinatal Fellow

Model Details: 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 Record Dates

• First Submitted: April 28, 2019
• First Posted: May 17, 2019
• Study Start: February 10, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)