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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

  • Procedure: PICC Placement by Landmark Technique
    • Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
  • 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

Arms, Groups and Cohorts

  • Active Comparator: Landmark Technique
    • Blinded method for catheter placement
  • Experimental: Ultrasound-guided Technique
    • Use sonography for catheter placement

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Equipo de Terapia Intravenosa
  • Collaborator
    • Hospital San Carlos, Madrid
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maria Montealegre, RN, IV Nurse, Study Director, Hospital Universitario Clinico San Carlos

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