N/A
N=60
Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
Venous Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02324504 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) — 40; 14; 8; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C3 Wave ECG-based PICC Tip Confirmation System (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) |
40; 14; 8; 18 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02324504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.