Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.

Venous Insufficiency Clinical Trial

— ECG-PICC  

Official title:

Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324504
• Other study ID #: IRB-P00015242
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.

Description:

The placement of peripherally inserted central catheters (PICCs) is an important component of medical care for a variety of patients. Current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications. Often the final catheter tip position may be uncertain based on radiographic imaging. Other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging. In adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is FDA approved. This study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a PICC, in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Age from birth to 17 years in need of a PICC as part of the medical treatment plan

• Suitable for an upper extremity PICC placement

• Hemodynamically stable, including patients stable on vasopressors

Exclusion Criteria:

• Hemodynamic instability

• Cardiac abnormality which leads to abnormal p-wave on ECG

• Arrhythmia at baseline, documented duirng the current hospital admission

• Presence of pacemaker or pacing wires which are currently actively pacing

• Patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava

• Premature neonate (<37 weeks estimated gestational age)

• Placement of PICC in lower extremity

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• C3 Wave ECG-based PICC Tip Confirmation System
The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)	Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of: RA SVC junction (right atrium/superior vena cava) or; Distal or lower SVC	Less than 24 hours