Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children. (ECG-PICC)

Boston Children's Hospital

Status: Completed

Conditions: Venous Insufficiency

Treatments: Device: C3 Wave ECG-based PICC Tip Confirmation System

Study type: Interventional

Funder types: Other

Identifiers

NCT02324504

IRB-P00015242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Placement with C3 Wave Tip System

Experimental group

Description:

Subjects will have their central catheters placed with the addition of the FDA approved C3 Wave ECG-Based PICC Tip Confirmation System to the standard institution protocol. The system will assist with location of the catheter tip in real-time, during the procedure.

Treatment:

Device: C3 Wave ECG-based PICC Tip Confirmation System