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OpenTrials
Completed

NCT Number: NCT02859987

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PICC Placement by Landmark Technique

Procedure

Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)

PICC Placement by Ultrasound-guided Technique

Procedure

Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)

Ultrasound scan

Device

Initially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Equipo de Terapia Intravenosa

Other

Collaborators

  • Hospital San Carlos, Madrid

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Aug 9, 2016
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.