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

NCT ID: NCT03028090

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Indication for Peripheral Intravenous Catheterization

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

SHERLOCK 3CG™ Tip Confirmation System with MODUS Software

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. is developing MODUS, a software package.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gina Gilbert, BSN

Role: STUDY_DIRECTOR

CR Bard

Locations

Memorial Health System

Colorado Springs, Colorado, United States

Bethesda North Hospital

Montgomery, Ohio, United States

Countries

United States

Other Identifiers

BAS-13-001

Identifier Type: -

Identifier Source: org_study_id