Clinical trial NCT03028090: Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System
Official title: A Two-Arm Prospective, Multi-Centered Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indication for Peripheral Intravenous Catheterization
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 182
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion
timeFrame: The PICC insertion procedure is 60-90 mins in duration
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Memorial Health System
state: Colorado
city: Montgomery
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: CR Bard
name: Gina Gilbert, BSN
role: STUDY_DIRECTOR
References: