Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System (MODUS)

A Two-Arm Prospective, Multi-Centered Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System

This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. The study was to promote the development of a software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform. All study participants received PICCs as their standard of care.

Study Overview

• Status: Completed
• Conditions: Indication for Peripheral Intravenous Catheterization
• Intervention / Treatment: Device: SHERLOCK 3CG™ Tip Confirmation System with MODUS Software

Detailed Description

The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or audio queues to notify the PICC placer of the location of the tip of the PICC relative to the cavoatrial junction of the patient.

Subjects who required bedside PICC placement as standard of care and met eligibility criteria were enrolled. The software package was not used in the guidance or placement of the PICC tip. PICCs were placed per standard of care procedure using anthropometric measurements with the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Health System
  • Ohio
    • Montgomery, Ohio, United States, 45242
      • Bethesda North Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population was to be comprised of a sufficient number of subjects so that a minimum of 201 subjects completed the study, but no more than 250 subjects were to be enrolled.

Description

Inclusion Criteria:

A subject must have met the following criteria to be enrolled in the study:

1. Male or female, age ≥ 21 years
2. Subject required PICC placement as part of standard of care
3. Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the subject's legally authorized representative

Exclusion Criteria:

• A subject was excluded if any of the following criteria were met:

  1. Subject had a contraindication to PICC placement as listed in the Instructions for Use (IFU)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion	The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.	The PICC insertion procedure is 60-90 mins in duration

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Study Director: Gina Gilbert, BSN, CR Bard

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BAS-13-001