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

C. R. Bard

Status: Terminated

Conditions: Primary Focus: Adult Subjects Who Require PICC Placement

Treatments: Device: ECG-guided PICC placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742053

Bard 3001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Device: ECG-guided PICC placement