Clinical trial NCT02324504: Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
Official title: Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: Peripherally Inserted Central Catheter (PICC)
Electrocardiographic guidance
Reposition
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 60
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
timeFrame: Less than 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Michael SD Agus, MD
role: PRINCIPAL_INVESTIGATOR
References: