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

NCT02859987 | Completed Phase 3

• 1 other identifier: ETI-HCSC-01
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PICC Placement

Keywords

US; Nursing Services

Outcome Measures

Primary Outcomes (1)

• Evidence of catheter inserted at first attempt, correctly located (after chest X-ray performed) and proper working, confirmed by the nurse

  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

Study Arms (2)

Landmark Technique

ACTIVE COMPARATOR

Blinded method for catheter placement

Procedure: PICC Placement by Landmark Technique

Ultrasound-guided Technique

EXPERIMENTAL

Use sonography for catheter placement

Procedure: PICC Placement by Ultrasound-guided Technique; Device: Ultrasound Scan

Interventions

PICC Placement by Landmark Technique PROCEDURE

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

Landmark Technique

PICC Placement by Ultrasound-guided Technique PROCEDURE

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

Ultrasound-guided Technique

Ultrasound Scan DEVICE

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

Ultrasound-guided Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Peripheral vascular disease
• Injecting drug users

Sponsors & Collaborators

• Equipo de Terapia Intravenosa: lead
• Hospital San Carlos, Madrid: collaborator

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria Montealegre, RN, IV Nurse

  Hospital Universitario Clinico San Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Last Updated: August 11, 2016

Record last verified: 2016-08