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

Not Applicable

Terminated

• Conditions: Primary Focus: Adult Subjects Who Require PICC Placement
• Interventions: Device: ECG-guided PICC placement

• Registration Number: NCT00742053
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Results First Submitted: 2012-04-25
• Results First Submitted QC: 2012-07-27
• Results First Posted: 2012-08-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ECG-guided PICC placement	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.

Primary Outcome Measures

Name	Time	Method
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction	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.

Trial Locations

Locations (1)

University of Utah Health Science Center; 🇺🇸 Salt Lake City, Utah, United States