We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement

This study has been terminated.
(Enrollment rate was too slow.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742053
First Posted: August 27, 2008
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
  Purpose

This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.

There is no formal study hypothesis.


Condition Intervention
Primary Focus: Adult Subjects Who Require PICC Placement Device: ECG-guided PICC placement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)

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

Primary Outcome Measures:
  • Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction [ Time Frame: during catheter insertion ]
    In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.


Enrollment: 7
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Male or female inpatients, age ≥ 18 and ≤ 80 years, who are in normal sinus rhythm and do not have a pacemaker or other indwelling intracardiac device and require PICC insertion for their routine care will be studied. Intervention: ECG-guided Power PICC placement.
Device: ECG-guided PICC placement
Patients undergoing PICC placement will have ECG data collected as a function of tip location.

Detailed Description:

PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.

Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Require Power PICC placement as standard care
  • Signed informed consent

Exclusion Criteria:

  • Has an intracardiac device
  • Does not have normal sinus rhythm
  • Has known abnormality of central venous system
  • Plasma creatinine >=1.5 mg/dL
  • Pregnancy
  • Allergy or prior reaction to contrast material
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742053


Locations
United States, Utah
University of Utah Health Science Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Andrew D Michaels, MD University of Utah Health Science Center
  More Information

Publications:
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00742053     History of Changes
Other Study ID Numbers: Bard 3001
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: April 25, 2012
Results First Posted: August 31, 2012
Last Update Posted: August 10, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by C. R. Bard:
ECG PICC
Patients undergoing PICC placement