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

Placement of Peripherally Inserted Central Catheters (PICC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742053
• Other study ID #: Bard 3001
• Status: Terminated
• Phase: N/A
• First received: August 25, 2008
• Last updated: July 27, 2012
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Placement of Peripherally Inserted Central Catheters (PICC)

Intervention

Device:
• ECG-guided PICC placement
Patients undergoing PICC placement will have ECG data collected as a function of tip location.

Locations

Country	Name	City	State
United States	University of Utah Health Science Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction	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.	during catheter insertion	No