Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation

No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement Clinical Trial

Official title:

Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation: A Comparison Between Standard of Care (Chest X-ray) and Sherlock 3CG® TCS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498821
• Other study ID #: BAS-14-004
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: July 1, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

The study is a cross-sectional, observational design, characterized as a time and motion study. The study will observe subjects and specific outcomes from the time a PICC insertion procedure begins until the subject is cleared for administration of their prescribed therapy. It will compare two approaches for PICC line placement and confirmation of PICC tip placement.

The two methods for placing and confirming PICC lines to be examined in this study are: 1) Standard of Care, defined as PICC line placement with Chest X-ray tip confirmation, and 2) Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. These two approaches are currently in use, and are not investigational.

The study will evaluate the time elapsed from the beginning of PICC line placement procedure through the catheter tip confirmation (subject released for IV therapy). A researcher will observe from the time the catheter kit is opened until your catheter is cleared for administration of treatment. Limited subject follow-up includes review of subject medical records related to the PICC line placement. Subjects will be followed only up to the point at which the PICC line tip has been confirmed and the subject has been released to receive IV therapy. For most subjects, all study data will be collected on Day 1.

The study is expected to include 120 subjects, 60 subjects will have confirmed PICC line placement using Chest X-ray, and 60 will have confirmed PICC line placement using Sherlock 3CG® TCS. Each group of subjects will be from two clinical sites using either tip confirmation method, for a total of 4 study sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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, polytetraflourine (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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement

Intervention

Device:
• X-ray
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.
• Sherlock 3CG® TCS
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.

Procedure:
• Peripherally Inserted Central Catheter (PICC)
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)

Locations

Country	Name	City	State
United States	University of Maryland - Baltimore	Baltimore	Maryland
United States	Florida Hospital	Maitland	Florida
United States	Unity Hospital	Rochester	New York
United States	Peninsula Regional Medical Center	Salisbury	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	KJT Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from initiation of procedure to release for IV therapy		intraoperative	No
Secondary	Total number of chest X-rays performed per subject		intraoperative	No
Secondary	Number of malpositions		intraoperative	No
Secondary	Procedures and materials needed to correct malpositions		intraoperative	No
Secondary	Health Care Professional procedural satisfaction		intraoperative	No
Secondary	Number of additional venous access devices (VADs) required due to PICC not being ready for use		intraoperative	No
Secondary	Number of missed doses due to PICC not being ready for use		intraoperative	No
Secondary	Number of missed lab draws due to PICC not being ready for use		intraoperative	No
Secondary	Number of overtime hours worked per PICC placement procedure		intraoperative	No