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

C. R. Bard

Status: Completed

Conditions: Indication for PICC Placement

Treatments: Device: Sherlock 3CG® TCS; Procedure: Peripherally Inserted Central Catheter (PICC); Device: Chest X-ray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02498821

BAS-14-004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Standard of Care (Chest X-ray)

Other group

Description:

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

Treatment:

Device: Chest X-ray

Procedure: Peripherally Inserted Central Catheter (PICC)

Sherlock 3CG® TCS

Other group

Description:

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.

Treatment:

Device: Sherlock 3CG® TCS

Procedure: Peripherally Inserted Central Catheter (PICC)