Randomized Controlled Trial of Ultrasound-guided Versus Landmark Technique for Peripherally Inserted Central Catheter (PICC) Placement

August 9, 2016 updated by: Equipo de Terapia Intravenosa

Peripherally Inserted Central Catheter (PICC) are intravascular devices used on patients undergoing IV therapy. Insertion of these catheters can be achieved either by using the anatomical landmarks for the veins or using ultrasound guidance. The guidelines recommend the use of ultrasound guidance for central venous access catheterization to facilitate central venous cannulation (CVC) and to reduce the risk of complications, but the scientific evidence is limited and heterogeneous.

This is a prospective randomized clinical trial in adults patients requiring peripherally inserted central catheter (PICC) placement for intravenous therapy.

The principal aim of this randomized clinical trial is to evaluate the effectiveness of ultrasound-guidance technique for successfully peripherally central venous catheterisation in the first attempt versus landmark method, in the context of PICC cannulation.

Patients are randomized (1:1) in two groups: Control arm (landmark technique) versus Experimental group (ultrasound guidance technique). In order to avoid expected biases the investigators stratified the cases by difficulty for venous cannulation. Crossover was allowed if catheterisation could not be reached after two unsuccessful venipunctures, to prevent suffering of the patients and troubles in its care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

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:

  • Signed and dated informed consent.
  • Patients with indication of PICC insertion for long-term intravenous therapy

Exclusion Criteria:

  • Peripheral vascular disease
  • Injecting drug users

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Landmark Technique
Blinded method for catheter placement
Procedure: PICC Placement by Landmark Technique
Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
EXPERIMENTAL: Ultrasound-guided Technique
Use sonography for catheter placement
Procedure: PICC Placement by Ultrasound-guided Technique
Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
Device: Ultrasound Scan
Initially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of catheter inserted at first attempt, correctly located (after chest X-ray performed) and proper working, confirmed by the nurse
Time Frame: Within the first 6 hours after placement
The principal aim is to evaluate the effectiveness of ultrasound-guidance technique for successfully peripherally central venous catheterisation in the first attempt versus landmark method, in the context of PICC cannulation
Within the first 6 hours after placement

Collaborators and Investigators

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

Sponsor

Equipo de Terapia Intravenosa

Collaborators

Hospital San Carlos, Madrid

Investigators

  • Study Director: Maria Montealegre, RN, IV Nurse, Hospital Universitario Clinico San Carlos

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

August 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ETI-HCSC-01

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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