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

This study has been terminated.
(Enrollment rate was too slow.)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00742053
First received: August 25, 2008
Last updated: July 27, 2012
Last verified: July 2012
  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
Placement of Peripherally Inserted Central Catheters (PICC)
Device: ECG-guided PICC placement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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
Patients who require PICC insertion for their care will be studied.
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided by C. R. Bard

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00742053     History of Changes
Other Study ID Numbers: Bard 3001
Study First Received: August 25, 2008
Results First Received: April 25, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014