NCT03652727

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

August 27, 2018

Last Update Submit

January 13, 2020

Conditions

Long Term AntibioticsChemotherapyTotal Parenteral Nutrition

Keywords

PICCPIC LineECG

Outcome Measures

Primary Outcomes (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.

    Up to 1 hour, after the procedure

Secondary Outcomes (2)

  • Length of the outgoing catheter

    Up to 1 hour, after the procedure

  • Inter-observer and intra-observer variance

    Through study completion, an average of 9 month

Study Arms (2)

ECG-EM Guidance

EXPERIMENTAL

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

FX Guidance

ACTIVE COMPARATOR

PICC insertion using fluoroscopic guidance

Device: FX Guidance

Interventions

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

ECG-EM Guidance
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

FX Guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33594912DERIVED

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Salah Dine Qanadli, Prof. MD PhD

    UNIL-CHUV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. MD PhD

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

September 4, 2018

Primary Completion

November 8, 2018

Study Completion

February 20, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)