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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Focus: Adult Subjects Who Require PICC Placement

Intervention / Treatment
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* Device: ECG-guided PICC placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Device: ECG-guided PICC placement<br>* Patients undergoing PICC placement will have ECG data collected as a function of tip location.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG PICC, Patients undergoing PICC placement