An interventional study of C3 Wave ECG-based PICC Tip Confirmation System in Venous Insufficiency, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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
Time frame: Less than 24 hours
Enrollment began in January 2016 and ended in December 2016. All subjects received the study intervention at Boston Children's Hospital (Boston, MA).
| Milestone | Intervention |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
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
| Participants | Total Enrolllment | Subjects Age 0-2 Years of Age | Subjects Age 3-11 Years of Age | Subjects Age 12-17 Years of Age |
|---|---|---|---|---|
| Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) | 40 | 14 | 8 | 18 |
Collected over Subjects were monitored for adverse events from the time of placement of the first electrode until confirmation of the PICC tip location via chest radiography or echocardiography, assessed up to 72 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 0/60 (0%) | 0/60 (0%) |
| Age, Customized(Participants) | Intervention |
|---|---|
| 0-2 Years | 23 |
| 3-11 Years | 14 |
| 12-17 Years | 23 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 31 |
| Male | 29 |
| Region of Enrollment(Participants) | Intervention |
|---|---|
| United States | 60 |
Plan to share: Yes — Will share with investigators based upon specific requests.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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