ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip

April 16, 2019 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised prospective single blinded study. All adult patients with an indication for PICC placement can be included. Patients will be randomised into two groups, one with ECG-guided placement followed by ultrasound control and the other with only ultrasound guided placement. After placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. For the ECG-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. For the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adults with indication for PICC

Exclusion Criteria:

  • Age <18y
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ECG-guided insertion of PICC
Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion.
Device: ECG-guided insertion of PICC
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
Device: ULTRASOUND-guided insertion of PICC
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
Experimental: ULTRASOUND-guided insertion of PICC
Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided.
Device: ECG-guided insertion of PICC
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
Device: ULTRASOUND-guided insertion of PICC
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion
Time Frame: Whitin 5 minutes after catheter-placement
The aim of the study is a comparison between two techniques to control correct positioning of the PICC
Whitin 5 minutes after catheter-placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
Time Frame: within 5 minutes
within 5 minutes
frequency of necessity of replacement after chest-x-ray control
Time Frame: 1 day
PICC tip should be located in the superior caval vein, close to the entrance of the right atrium. Other locations lead to repositioning.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Lucie Choustoulakis, MD, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
  • Study Chair: Jan Poelaert, MD, PhD, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
  • Principal Investigator: Matthias Raes, MD, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECG-PICC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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