Clinical trial NCT02498821: Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indication for PICC Placement
Keywords: PICC
central catheter
vascular access
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: KJT Group, Inc.
First posted: 2015-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).
timeFrame: Usually ranges from 0 to 300 minutes from initiation of procedure
Secondary outcomes:
measure: Total Number of Chest X-rays Performed Per Subject
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Number of Participants With Malpositions
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Number of Subsequent Malposition Attempts
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Health Care Professional (HCP) Procedural Satisfaction (Overall)
timeFrame: Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).
measure: Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Number of Medication Doses Missed Due to PICC Not Being Ready for Use
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Number of Lab Draws Missed Due to PICC Not Being Ready for Use
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
measure: Number of Overtime Hours Worked Per PICC Placement Procedure
timeFrame: Measured from initiation to completion of procedure (usually from 0 to 5 hours)
Other outcomes:
measure: Nurse Time Associated With Initial PICC Placement (Per Patient)
timeFrame: Usually ranges from 0 to 150 minutes
measure: Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)
timeFrame: Usually ranges from 0 to 30 minutes
measure: Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)
timeFrame: Usually ranges from 0 to 300 minutes
Locations:
city: Maitland
country: United States
facility: Florida Hospital
state: Florida
city: Baltimore
country: United States
facility: University of Maryland - Baltimore
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Rochester
country: United States
facility: Unity Hospital
state: New York
Study officials:
affiliation: KJT Group, Inc.
name: Kenneth J Tomaszewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: