NCT02498821

Brief Summary

The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 3, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

July 1, 2015

Results QC Date

January 12, 2017

Last Update Submit

March 2, 2017

Conditions

Indication for PICC Placement

Keywords

PICCcentral cathetervascular access

Outcome Measures

Primary Outcomes (1)

  • Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).

    Usually ranges from 0 to 300 minutes from initiation of procedure

Secondary Outcomes (8)

  • Total Number of Chest X-rays Performed Per Subject

    Measured from initiation to completion of procedure (usually from 0 to 300 minutes)

  • Number of Participants With Malpositions

    Measured from initiation to completion of procedure (usually from 0 to 300 minutes)

  • Number of Subsequent Malposition Attempts

    Measured from initiation to completion of procedure (usually from 0 to 300 minutes)

  • Health Care Professional (HCP) Procedural Satisfaction (Overall)

    Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).

  • Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use

    Measured from initiation to completion of procedure (usually from 0 to 300 minutes)

  • +3 more secondary outcomes

Other Outcomes (3)

  • Nurse Time Associated With Initial PICC Placement (Per Patient)

    Usually ranges from 0 to 150 minutes

  • Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)

    Usually ranges from 0 to 30 minutes

  • Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)

    Usually ranges from 0 to 300 minutes

Study Arms (2)

Standard of Care (Chest X-ray)

OTHER

Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).

Device: Chest X-rayProcedure: Peripherally Inserted Central Catheter (PICC)

Sherlock 3CG® TCS

OTHER

Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.

Device: Sherlock 3CG® TCSProcedure: Peripherally Inserted Central Catheter (PICC)

Interventions

Chest X-rayDEVICE

A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.

Standard of Care (Chest X-ray)
Sherlock 3CG® TCSDEVICE

The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.

Sherlock 3CG® TCS
Peripherally Inserted Central Catheter (PICC)PROCEDURE

A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)

Sherlock 3CG® TCSStandard of Care (Chest X-ray)

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indicated for a PICC based on institutional practices.
  • Able to read and comprehend English and has signed the Informed Consent Form to participate in the study.
  • PICC line is placed while a study observer is available and on the study site at the time of the placement.

You may not qualify if:

  • Infection, bacteremia, or septicemia is known or suspected.
  • Body size is insufficient to accommodate the size of the implanted device.
  • Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors will prevent proper device stabilization and/or access.
  • Under the age of 22.
  • Receiving the PICC as a replacement with an over-the-wire exchange.
  • Pregnant or lactating.
  • Anatomical irregularities (structural and vascular of the central venous system) which may compromise catheter insertion in both the primary arm and contralateral arm.
  • Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.
  • Artificial heart or heart transplant.
  • Anatomical abnormalities of the central venous system.
  • Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
  • Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Florida Hospital

Maitland, Florida, 32751, United States

Location

University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Unity Hospital

Rochester, New York, 14626, United States

Location

MeSH Terms

Interventions

Diagnostic ImagingCatheterization, Peripheral

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Results Point of Contact

Title
Gina Gilbert, BSN, RN
Organization
Bard Access Systems, Inc.
Gina.Gilbert@crbard.com
407-489-0835

Study Officials

  • Kenneth J Tomaszewski, PhD

    KJT Group, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 15, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 31, 2017

Results First Posted

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)