Clinical trial NCT03652727: FX vs. ECG Guidance for PICC Insertion
Official title: Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Term Antibiotics
Chemotherapy
Total Parenteral Nutrition
Keywords: PICC
PIC Line
ECG
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2018-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Tip to CAJ (Cavo-atrial junction)
timeFrame: Up to 1 hour, after the procedure
Secondary outcomes:
measure: Length of the outgoing catheter
timeFrame: Up to 1 hour, after the procedure
measure: Inter-observer and intra-observer variance
timeFrame: Through study completion, an average of 9 month
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: UNIL-CHUV
name: Salah Dine Qanadli, Prof. MD PhD
role: STUDY_DIRECTOR
References:
citation: Gullo G, Colin A, Frossard P, Jouannic AM, Knebel JF, Qanadli SD. Appropriateness of Replacing Fluoroscopic Guidance With ECG-Electromagnetic Guidance for PICC Insertion: A Randomized Controlled Trial. AJR Am J Roentgenol. 2021 Apr;216(4):981-988. doi: 10.2214/AJR.20.23345. Epub 2021 Feb 17.