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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: C3 Wave ECG-based PICC Tip Confirmation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placement with C3 Wave Tip System<br>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. | Device: C3 Wave ECG-based PICC Tip Confirmation System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripherally Inserted Central Catheter (PICC), Electrocardiographic guidance, Reposition