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

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

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).

Study Overview

• Status: Completed
• Conditions: Indication for PICC Placement
• Intervention / Treatment: Device: Chest X-ray; Procedure: Peripherally Inserted Central Catheter (PICC); Device: Sherlock 3CG® TCS

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Florida Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland - Baltimore
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • New York
    • Rochester, New York, United States, 14626
      • Unity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Device: 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.; 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)
Other: 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.	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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.	Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Health Care Professional (HCP) Procedural Satisfaction (Overall)	HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning "not at all satisfied" and 10 meaning "extremely satisfied".	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)
Number of Medication Doses Missed Due to PICC Not Being Ready for Use		Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Lab Draws Missed Due to PICC Not Being Ready for Use		Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
Number of Overtime Hours Worked Per PICC Placement Procedure		Measured from initiation to completion of procedure (usually from 0 to 5 hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurse Time Associated With Initial PICC Placement (Per Patient)	Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject's room) and any consents obtained for the PICC procedure (not study-related consents).	Usually ranges from 0 to 150 minutes
Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)	Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy.	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)	Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion).	Usually ranges from 0 to 300 minutes

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: KJT Group, Inc.
• Investigators: Principal Investigator: Kenneth J Tomaszewski, PhD, KJT Group, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: vascular access; PICC; central catheter
• Other Study ID Numbers: BAS-14-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No