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Long Term AntibioticsNCT03652727

FX vs. ECG Guidance for PICC Insertion

A study testing ECG-EM Guidance and FX Guidance in people with Long Term Antibiotics and Chemotherapy, run by Salah D. Qanadli at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ECG-EM Guidance and FX Guidance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSwitzerland
Study dates
4 Sep 2018to 20 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent as documented by signature (Informed Consent Form)
  • Adult > 18 years
  • Referred to the interventional radiology department for PICC insertion

Who cannot join

  • 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)
Show all 9Show fewer
  • Enrolled in conflicting research study
  • Weight> 150 kg, technical limit for the fluoroscopy table
  • Impossibility of obtaining informed consent

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • CHUV

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

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

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).

Read the 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.

Being tested
ECG-EM Guidance, FX Guidance
Keywords
PICC, PIC Line, ECG
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECG-EM GuidanceDevice

    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

  • FX GuidanceDevice

    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

Study groups in NCT03652727
Study groupRoleWhat they receive
ECG-EM GuidanceExperimentalPICC insertion using electrocardiographic and electromagnetic guidance [Site~Rite® 8 Ultrasound System with integrated SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS)]
Receives: Device: ECG-EM Guidance
FX GuidanceActive comparatorPICC insertion using fluoroscopic guidance
Receives: Device: FX Guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tip to CAJ (Cavo-atrial junction)

    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.

    Measured: Up to 1 hour, after the procedure

Secondary outcomes (2)

  1. Length of the outgoing catheter

    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

    Measured: Up to 1 hour, after the procedure

  2. Inter-observer and intra-observer variance

    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

    Measured: Through study completion, an average of 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start4 Sep 2018
  3. Primary completion8 Nov 2018
  4. Study completion20 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03652727
Sponsor's protocol ID
2018-00907
Other IDs
2018
Status last verified
Jan 2020
First submitted
27 Aug 2018
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33594912

Questions about this trial

What is this clinical trial studying?

A study testing ECG-EM Guidance and FX Guidance in people with Long Term Antibiotics and Chemotherapy, run by Salah D. Qanadli at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tip to CAJ (Cavo-atrial junction) (time frame: Up to 1 hour, after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03652727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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