Assessment of the Precision of the Sherlock 3CG Tip Positioning System - Full Text View

Purpose

Phase I

determine the location of the peripherally inserted central catheter (PICC) tip upon observation of maximum p-wave amplitude

Phase II

determine the precision of PICC placement in the Sherlock 3CG group versus the standard PICC placement

Condition	Intervention
Peripherally Inserted Central Catheters	Device: Sherlock 3CG Other: Blind Placement

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Official Title:	A Study to Assess the Precision of the Sherlock 3CG Tip Positioning System as a Tool to Guide Peripherally Inserted Central Catheter Placement

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

Phase I - to determine the location of the PICC tip upon observation of maximum p-wave amplitude using Sherlock 3CG. [ Time Frame: Time of PICC placement (Day 0) ] [ Designated as safety issue: No ]
To determine the mean distance from the PICC tip to the upper cavoatrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
Phase II - To determine the precision of PICC placement in the Sherlock 3CG group (treatment arm) relative to the blind placement group (control arm) using the upper cavoatrial junction as an anatomical landmark. [ Time Frame: Time of PICC placement (Day 0) ] [ Designated as safety issue: No ]
to determine the mean distance from the PICC tip to the upper cavoatrial junction, as measured by the qualified radiology practitioner based on ACT imaging. Mean distances will be calculated for both the Sherlock 3CG group and the blind placement group.

Secondary Outcome Measures:

Phase I: To evaluate the distance necessary for repositioning, if necessary, of the PICC tip upon observation of the maximum p-wave amplitude [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine the mean distance of the PICC tip to the upper cavoatrial junction following repositioning, if necessary.
Phase I: To assess capability of Angiographic CT to image the PICC tip when using Sherlock 3CG for PICC placement [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine the proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed.

Note - this endpoint is to assess the diagnostic capability of ACT. It is not designed to reflect on PICC tip location.
Phase I: To determine if there is a difference in the location of the cavoatrial junction on Angiographic CT performed with the arms above the head or at the subject's side. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine whether measurements of the location of the cavoatrial junction on Angiographic CT differs by greater than 5mm between acquisitions obtained with the arms above the head & arms at the side of the subject.
Phase I: To determine the amount of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine the mean distance of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side.
Phase II: To assess adverse events associated with the use of Sherlock 3CG for PICC placement. [ Time Frame: 30 Days post procedure ] [ Designated as safety issue: Yes ]
To determine the proportion of subjects experiencing device-or-procedure related adverse events in the Sherlock 3CG group and in the blind placement group.
Phase II: To determine the success rate of placing the PICC tip into an acceptable position using the Sherlock 3CG, as judged by the qualified radiology practitioners. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine the proportion of subjects in whom the PICC tip was in an acceptable position in the Sherlock 3CG group and in the blind placement group.
Phase II: To determine the number of radiographs received in each subject group. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To assess the mean number of spot images that are used in the Sherlock 3CG and in the blind placement group.
Phase II: To determine the amount of radiation received in each subject group. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
To determine the mean radiation received by the Sherlock 3CG and blind placement groups.

Enrollment:	27
Study Start Date:	January 2011
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sherlock 3CG Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.	Device: Sherlock 3CG Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Active Comparator: "Blind" Placement PICCs will be placed "blindly", without the use of any tip location/positioning device.	Other: Blind Placement PICCs will be placed "blindly", without the use of any tip location/positioning device.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, age ≥ 21years
Require 5 F dual lumen or 4 F single lumen PowerPICC or PowerPICC SOLO placement as part of standard care
Be able to undergo study procedures
Subject is able to comply with all study requirements and be available for 30 day follow-up visit.
Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative

Exclusion Criteria:

Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) (See Section 18.2)
Subject has been previously randomized for this study.
Subject is unable to lie in the supine position on the fluoroscopy table
Subject had radiation therapy within the last three years
Subject has an existing pregnancy
Subject has known glomerular filtration rate (GFR) <45 ml/min/1.73m2
Subject has a functioning pacemaker or defibrillator
Subject has an artificial heart or heart transplant
Subject has anatomical abnormalities of the central venous system
Subject has atrial fibrillation or other atrial arrhythmias in which a p-wave was not consistently present on ECG
Subject has internal wires that may interfere with imaging
Subject has an existing central venous catheter
Subject is unable to raise arms above the head while lying flat.
Subject has a BMI ≥45
The clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275430

Locations

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

C. R. Bard

Investigators

Principal Investigator:

Gordon McLennan, M.D.

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT01275430 History of Changes
Other Study ID Numbers:	BAS-3004
Study First Received:	January 11, 2011
Last Updated:	April 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by C. R. Bard:

central venous catheters
peripherally inserted central catheters (PICC_
Electrocardiography (ECG)
intravascular ECG
Tip Positioning System

ClinicalTrials.gov processed this record on October 18, 2012

Assessment of the Precision of the Sherlock 3CG Tip Positioning System (STAT-PICC)