Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

FX vs. ECG Guidance for PICC Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652727
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Salah D. Qanadli, University of Lausanne

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).

Condition or disease Intervention/treatment Phase
Long Term Antibiotics Chemotherapy Total Parenteral Nutrition Device: ECG-EM Guidance Device: FX Guidance Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : February 20, 2019

Arm Intervention/treatment
Experimental: ECG-EM Guidance
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

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


Active Comparator: FX Guidance
PICC insertion using fluoroscopic guidance
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





Primary Outcome Measures :
  1. Tip to CAJ (Cavo-atrial junction) [ Time Frame: Up to 1 hour, after the procedure ]

    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.



Secondary Outcome Measures :
  1. Length of the outgoing catheter [ Time Frame: Up to 1 hour, after the procedure ]
    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

  2. Inter-observer and intra-observer variance [ Time Frame: Through study completion, an average of 9 month ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652727


Locations
Layout table for location information
Switzerland
CHUV
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Salah D. Qanadli
Centre Hospitalier Universitaire Vaudois
Investigators
Layout table for investigator information
Study Director: Salah Dine Qanadli, Prof. MD PhD UNIL-CHUV

Layout table for additonal information
Responsible Party: Salah D. Qanadli, Prof. MD PhD, University of Lausanne
ClinicalTrials.gov Identifier: NCT03652727    
Other Study ID Numbers: 2018-00907
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salah D. Qanadli, University of Lausanne:
PICC
PIC Line
ECG