Venous Insufficiency
Conditions
Keywords
Peripherally Inserted Central Catheter (PICC), Electrocardiographic guidance, Reposition
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.
Interventions
DEVICEC3 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.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Enrollment began in January 2016 and ended in December 2016. All subjects received the study intervention at Boston Children's Hospital (Boston, MA).
Pre-assignment details
Participants (or appropriate parent/guardian) gave consent prior to placement of the peripherally inserted central catheter (PICC).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Customized 0-2 Years | 23 Participants |
| Age, Customized 12-17 Years | 23 Participants |
| Age, Customized 3-11 Years | 14 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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: * RA SVC junction (right atrium/superior vena cava) or * Distal or lower SVC
Time frame: Less than 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Enrolllment | Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) | 40 Participants |
| Subjects Age 0-2 Years of Age | Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) | 14 Participants |
| Subjects Age 3-11 Years of Age | Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) | 8 Participants |
| Subjects Age 12-17 Years of Age | Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) | 18 Participants |