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

Completed

• Conditions: Indication for Peripheral Intravenous Catheterization

• Registration Number: NCT03028090
• Lead Sponsor: C. R. Bard

Brief Summary

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.

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion	The PICC insertion procedure is 60-90 mins in duration	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.

Trial Locations

Locations (2)

Memorial Health System; 🇺🇸 Colorado Springs, Colorado, United States

Bethesda North Hospital; 🇺🇸 Montgomery, Ohio, United States