FX vs. ECG Guidance for PICC Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare two techniques of placing a peripherally inserted central venous catheter (PICC). The first technique, uses ECG based electromagnetic guidance (ECG-EM). The second (reference technique), is guided by X-ray (fluoroscopy).

Detailed Description
-----------------
The method of placement under fluoroscopic control (FX) is considered as the reference technique. This is often criticized for disadvantages such as costs, logistical problems and relative ionizing radiation. Despite this, it is still advised by 75% of PICC providers. Appeared about ten years ago, a per procedural guiding technique with intracavitary ECG tracking (ECG-EM) presents a better technical success (precision and specificity) than the blind technique, but there is still a lack in comparing this technique to the FX technique. This prospective randomized controlled study is designed to compare the PICC insertion using ECG-EM guidance to fluoroscopic (FX) guidance in order to define whether a replacement of the FX technique by ECG-EM is appropriate in terms of the final catheter tip position of the PICC as well as length of the outgoing catheter at the entry point. All included patients gave their written consent and the study is approved by EC. Participation is open to all adults referred to the radiology department of the CHUV for insertion of a PICC (monocentric). Recruited patients will be randomly assigned to one of the two arms (FX or ECG-EM). For both procedures patient position and preparation (MSB, maximal sterile barrier) are standardized and are similar. FX method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. Through the point of puncture, a long wire is then introduced and directed to the level of the target zone located in the superior vena cava under fluoroscopy control. The length of the guide inside the vessel is then measured to adjust the length of the PICC necessary for its optimal positioning. For ECG-EM insertion technique, the vein puncture is done in similar conditions to the FX method. The length of the PICC is estimated prior to its insertion using morphological landmarks. The placement of the PICC is done using SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) (CE marked device; C. R. Bard, Inc.). At the end of procedure, a chest x-ray is performed to assess the PICC position. Possible per-procedural complications are documented. After intervention, the patient is transferred back to the ward or sent home in stable conditions.

Official Title
-----------------
Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT

Conditions
-----------------
Chemotherapy, Long Term Antibiotics, Total Parenteral Nutrition

Intervention / Treatment
-----------------
* Device: ECG-EM Guidance
* Device: FX Guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent as documented by signature (Informed Consent Form) Adult > 18 years Referred to the interventional radiology department for PICC insertion Exclusion Criteria: Pregnant women Known or suspected non-compliance Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, Previous enrolment into the current study, Enrolment of the investigator, his/her family members, employees and other dependent persons, Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm) Enrolled in conflicting research study Weight> 150 kg, technical limit for the fluoroscopy table Impossibility of obtaining informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECG-EM Guidance<br>PICC insertion using electrocardiographic and electromagnetic guidance [Site Rite® 8 Ultrasound System with integrated SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS)] | Device: ECG-EM Guidance<br>* ECG-EM method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. The length of the PICC is estimated prior to its insertion using morphological landmarks. The placement of the PICC is done using SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) [CE marked device, C. R. Bard, Inc.]. At the end of procedure, a chest x-ray is performed to assess the PICC position<br>|
| Active Comparator: FX Guidance<br>PICC insertion using fluoroscopic guidance | Device: FX Guidance<br>* FX method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. Through the point of puncture, a long wire is then introduced and directed to the level of the target zone located in the superior vena cava under fluoroscopy control. The length of the guide inside the vessel is then measured to adjust the length of the PICC necessary for its optimal positioning. At the end of procedure, a chest x-ray is performed to assess the PICC position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tip to CAJ (Cavo-atrial junction) | At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance from tip to CAJ is measured on the image. This will reflect proportions of optimal tip positions depending on guidance technology. Rationale is that optimal position is mandatory for adequate functioning of PICC as malpositions may result on cardiac rhythm disorders, thrombosis or premature PICC occlusion. | Up to 1 hour, after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the outgoing catheter | Length of the outgoing catheter at the entry point near the bend of the elbow. The rationale behind is that correct positioning guarantees optimal haemostasis and might prevent secondary displacement | Up to 1 hour, after the procedure | 
| Inter-observer and intra-observer variance | The CAJ to catheter tip distance is based on subjective assessment by one investigator of the X-ray chest. Rationale behind is that in order to evaluate the impact of potential variation due to subjective interpretation interobserver and intraobserver variance will be quantified | Through study completion, an average of 9 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PICC, PIC Line, ECG