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

NCT ID: NCT02498821

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-05-31

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).

Detailed 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.

Conditions

Indication for PICC Placement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard of Care (Chest X-ray)

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

Group Type: OTHER

Chest X-ray

Intervention Type: DEVICE

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.

Peripherally Inserted Central Catheter (PICC)

Intervention Type: 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® TCS

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.

Group Type: OTHER

Sherlock 3CG® TCS

Intervention Type: DEVICE

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.

Peripherally Inserted Central Catheter (PICC)

Intervention Type: 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)

Interventions

Chest 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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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, 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KJT Group, Inc.

INDUSTRY

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth J Tomaszewski, PhD

Role: PRINCIPAL_INVESTIGATOR

KJT Group, Inc.

Locations

Florida Hospital

Maitland, Florida, United States

University of Maryland - Baltimore

Baltimore, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Unity Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

BAS-14-004

Identifier Type: -

Identifier Source: org_study_id