Trial Outcomes & Findings for Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children. (NCT NCT02324504)
NCT ID: NCT02324504
Last Updated: 2022-07-25
Results Overview
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
COMPLETED
NA
60 participants
Less than 24 hours
2022-07-25
Participant Flow
Enrollment began in January 2016 and ended in December 2016. All subjects received the study intervention at Boston Children's Hospital (Boston, MA).
Participants (or appropriate parent/guardian) gave consent prior to placement of the peripherally inserted central catheter (PICC).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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60
|
|
Overall Study
COMPLETED
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60
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
Baseline characteristics by cohort
| Measure |
Intervention
n=60 Participants
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.
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|---|---|
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Age, Customized
0-2 Years
|
23 Participants
n=99 Participants
|
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Age, Customized
3-11 Years
|
14 Participants
n=99 Participants
|
|
Age, Customized
12-17 Years
|
23 Participants
n=99 Participants
|
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Sex: Female, Male
Female
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31 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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29 Participants
n=99 Participants
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Region of Enrollment
United States
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60 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Less than 24 hoursSuccessful 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
Outcome measures
| Measure |
Total Enrolllment
n=60 Participants
All subjects (less than 18 years of age) will have PICC placement 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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Subjects Age 0-2 Years of Age
n=23 Participants
Approximately 38% of the enrolled subjects were two years of age or younger. 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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Subjects Age 3-11 Years of Age
n=14 Participants
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.
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Subjects Age 12-17 Years of Age
n=23 Participants
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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|---|---|---|---|---|
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Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
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40 Participants
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14 Participants
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8 Participants
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18 Participants
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Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place