Comparison of Two ECG Guided PICC Insertion Techniques

Study Overview
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Brief Summary
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The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.

Detailed Description
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One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment

Official Title
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Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial

Conditions
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Central Venous Access, Long Term Antibiotics, Chemotherapy, Total Parenteral Nutrition

Intervention / Treatment
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* Device: LifeCath-CT PICC easy™ (Vygon)
* Device: PowerPICC-SOLO® (C.R. Bard)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) Adult > 18 years Referred to the interventional radiology department for PICC insertion Exclusion Criteria: 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 Refusal to be informed in the event of a chance discovery

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline ECG with Pilot Tip Location System<br>PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water | Device: LifeCath-CT PICC easy™ (Vygon)<br>* ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity. The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve. The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.<br>|
| Experimental: Guidewire ECG with Sherlock Tip Confirmation System<br>PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire | Device: PowerPICC-SOLO® (C.R. Bard)<br>* ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside. The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance from catheter tip to cavo-atrial junction (CAJ) | At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance in centimeters from tip to CAJ is measured on the image | At the end of intervention | 

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 in centimeters | At the end of intervention | 
| Haemostasis time | Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes) | At the end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICC, ECG guidance, Central Venous Catheter, Catheterization