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

Not Applicable

Completed

Brief 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.

Detailed 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 & 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

Arm && Interventions

Group	Intervention	Description
Placement with C3 Wave Tip System	C3 Wave ECG-based PICC Tip Confirmation System	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)	Less than 24 hours	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

Secondary Outcome Measures