Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation

Study Overview
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Brief Summary
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The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).

Detailed Description
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The study is a cross-sectional, observational design, characterized as a time and motion study. The study will observe subjects and specific outcomes from the time a PICC insertion procedure begins until the subject is cleared for administration of their prescribed therapy. It will compare two approaches for PICC line placement and confirmation of PICC tip placement. The two methods for placing and confirming PICC lines to be examined in this study are: 1) Standard of Care, defined as PICC line placement with Chest X-ray tip confirmation, and 2) Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. These two approaches are currently in use, and are not investigational. The study will evaluate the time elapsed from the beginning of PICC line placement procedure through the catheter tip confirmation (subject released for IV therapy). A researcher will observe from the time the catheter kit is opened until your catheter is cleared for administration of treatment. Limited subject follow-up includes review of subject medical records related to the PICC line placement. Subjects will be followed only up to the point at which the PICC line tip has been confirmed and the subject has been released to receive IV therapy. For most subjects, all study data will be collected on Day 1. The study is expected to include 120 subjects, 60 subjects will have confirmed PICC line placement using Chest X-ray, and 60 will have confirmed PICC line placement using Sherlock 3CG® TCS. Each group of subjects will be from two clinical sites using either tip confirmation method, for a total of 4 study sites.

Official Title
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Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation: A Comparison Between Standard of Care (Chest X-ray) and Sherlock 3CG® TCS

Conditions
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Indication for PICC Placement

Intervention / Treatment
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* Device: Chest X-ray
* Device: Sherlock 3CG® TCS
* Procedure: Peripherally Inserted Central Catheter (PICC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indicated for a PICC based on institutional practices. Able to read and comprehend English and has signed the Informed Consent Form to participate in the study. PICC line is placed while a study observer is available and on the study site at the time of the placement. Exclusion Criteria: Infection, bacteremia, or septicemia is known or suspected. Body size is insufficient to accommodate the size of the implanted device. Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium. Past irradiation of prospective insertion site. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site. Local tissue factors will prevent proper device stabilization and/or access. Under the age of 22. Receiving the PICC as a replacement with an over-the-wire exchange. Pregnant or lactating. Anatomical irregularities (structural and vascular of the central venous system) which may compromise catheter insertion in both the primary arm and contralateral arm. Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation. Artificial heart or heart transplant. Anatomical abnormalities of the central venous system. Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG. Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.

Ages Eligible for Study
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Minimum Age: 22 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care (Chest X-ray)<br>Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray). | Device: Chest X-ray<br>* A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.<br>Procedure: Peripherally Inserted Central Catheter (PICC)<br>* A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)<br>|
| Other: Sherlock 3CG® TCS<br>Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. | Device: Sherlock 3CG® TCS<br>* The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.<br>Procedure: Peripherally Inserted Central Catheter (PICC)<br>* A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). |  | Usually ranges from 0 to 300 minutes from initiation of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Chest X-rays Performed Per Subject |  | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Number of Participants With Malpositions |  | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Number of Subsequent Malposition Attempts | This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt. | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Health Care Professional (HCP) Procedural Satisfaction (Overall) | HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning not at all satisfied and 10 meaning extremely satisfied. | Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation). | 
| Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use |  | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Number of Medication Doses Missed Due to PICC Not Being Ready for Use |  | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Number of Lab Draws Missed Due to PICC Not Being Ready for Use |  | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | 
| Number of Overtime Hours Worked Per PICC Placement Procedure |  | Measured from initiation to completion of procedure (usually from 0 to 5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICC, central catheter, vascular access