Comparison of Two ECG Guided PICC Insertion Techniques

University of Lausanne (UNIL)

Status: Completed

Conditions: Central Venous Access; Chemotherapy; Total Parenteral Nutrition; Long Term Antibiotics

Treatments: Device: LifeCath-CT PICC easy™ (Vygon); Device: PowerPICC-SOLO® (C.R. Bard)

Study type: Interventional

Funder types: Other

Identifiers

NCT04466332

2020-00583

Details and patient eligibility

About

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.

Full description

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

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Saline ECG with Pilot Tip Location System

Experimental group

Description:

PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water

Treatment:

Device: LifeCath-CT PICC easy™ (Vygon)

Guidewire ECG with Sherlock Tip Confirmation System

Experimental group

Description:

PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire

Treatment:

Device: PowerPICC-SOLO® (C.R. Bard)