Skip to main content
Clinical Trials/NCT00742053
NCT00742053
Terminated
Not Applicable

A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)

C. R. Bard1 site in 1 country7 target enrollmentJune 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Focus: Adult Subjects Who Require PICC Placement
Sponsor
C. R. Bard
Enrollment
7
Locations
1
Primary Endpoint
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction
Status
Terminated
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
March 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
C. R. Bard
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials