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

NCT ID: NCT00742053

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-03-31

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.

Conditions

Primary Focus: Adult Subjects Who Require PICC Placement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ECG-guided PICC placement

Intervention Type: DEVICE

Patients undergoing PICC placement will have ECG data collected as a function of tip location.

Interventions

ECG-guided PICC placement

Patients undergoing PICC placement will have ECG data collected as a function of tip location.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew D Michaels, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Health Science Center

Locations

University of Utah Health Science Center

Salt Lake City, Utah, United States

Countries

United States

References

Smith B, Neuharth RM, Hendrix MA, McDonnall D, Michaels AD. Intravenous electrocardiographic guidance for placement of peripherally inserted central catheters. J Electrocardiol. 2010 May-Jun;43(3):274-8. doi: 10.1016/j.jelectrocard.2010.02.003. Epub 2010 Mar 6.

Reference Type: BACKGROUND

PMID: 20206940 (View on PubMed)

Other Identifiers

Bard 3001

Identifier Type: -

Identifier Source: org_study_id