Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.

NCT02324504 | Completed Results

• 1 other identifier: IRB-P00015242
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency

Keywords

Peripherally Inserted Central Catheter (PICC); Electrocardiographic guidance; Reposition

Outcome Measures

Primary Outcomes (1)

• 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

  Less than 24 hours

Study Arms (1)

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.

Device: C3 Wave ECG-based PICC Tip Confirmation System

Interventions

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.

Placement with C3 Wave Tip System

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Michael Agus
• Organization: Boston Children's Hospital

michael.agus@childrens.harvard.edu

617 355-5849

Study Officials

• Michael SD Agus, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: July 25, 2022
• Results First Posted: February 23, 2018

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)