NCT03652727

FX vs. ECG Guidance for PICC Insertion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Salah D. Qanadli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long Term Antibiotics
• Chemotherapy
• Total Parenteral Nutrition

Interventions

Type	Name	Description
DEVICE	ECG-EM Guidance	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
DEVICE	FX Guidance	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

Timeline

• Start date: 2018-09-04
• Primary completion: 2018-11-08
• Completion: 2019-02-20
• First posted: 2018-08-29
• Last updated: 2020-01-14

Locations

1 site across 1 country: Switzerland