NCT02324504

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2014-12-24
• Last updated: 2022-07-25
• Results posted: 2018-02-23

Locations

1 site across 1 country: United States