PUP: Point of Care Ultrasound for PICC Line Monitoring Study

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03954977
Collaborator
University of Washington (Other)
30
2
1
6.6
15
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PICC line ultrasound
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Masking Description:
Investigator is blinded to xray result before doing ultrasound
Primary Purpose:
Screening
Official Title:
Point of Care Ultrasound for PICC Line Monitoring Study
Actual Study Start Date :
Feb 10, 2019
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. PICC line tip is located by the ultrasound operator [6 months]

    PICC line identified under ultrasound

Secondary Outcome Measures

  1. PICC line location on ultrasound agrees with radiograph [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Childrens Hospital Seattle Washington United States 98105
2 University Of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • Seattle Children's Hospital
  • University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Motz, Neonatal Perinatal Fellow, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT03954977
Other Study ID Numbers:
  • 0503
First Posted:
May 17, 2019
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Patrick Motz, Neonatal Perinatal Fellow, Seattle Children's Hospital

Study Results

No Results Posted as of Sep 26, 2019