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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placement with C3 Wave Tip System | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C3 Wave ECG-based PICC Tip Confirmation System | Device | 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. |
| 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:
| Less than 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael SD Agus, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
Will share with investigators based upon specific requests.
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Participants (or appropriate parent/guardian) gave consent prior to placement of the peripherally inserted central catheter (PICC).
Enrollment began in January 2016 and ended in December 2016. All subjects received the study intervention at Boston Children's Hospital (Boston, MA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure. 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 connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement. Standard care chest radiograph will be performed as a second measure to confirm catheter tip placement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure. 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. Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | Less than 24 hours |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure. 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 connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement. Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Agus | Boston Children's Hospital | 617 355-5849 | michael.agus@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Subjects Age 3-11 Years of Age | Approximately 23% of the enrolled subjects were between the ages of 3 and 11 years. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates. |
| OG003 | Subjects Age 12-17 Years of Age | Approximately 38% of the enrolled subjects were between 12 and 17 years of age. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates. |
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| 0 |
| 60 |
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| 60 |
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