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

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. Identifier: NCT00742053
Recruitment Status : Terminated (Enrollment rate was too slow.)
First Posted : August 27, 2008
Results First Posted : August 31, 2012
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Focus: Adult Subjects Who Require PICC Placement Device: ECG-guided PICC placement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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)
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00742053

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

Responsible Party: C. R. Bard Identifier: NCT00742053     History of Changes
Other Study ID Numbers: Bard 3001
First Posted: August 27, 2008    Key Record Dates
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:
Patients undergoing PICC placement