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

NCT ID: NCT02859987

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Landmark Technique

Blinded method for catheter placement

Group Type: ACTIVE_COMPARATOR

PICC Placement by Landmark Technique

Intervention Type: PROCEDURE

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

Ultrasound-guided Technique

Use sonography for catheter placement

Group Type: EXPERIMENTAL

PICC Placement by Ultrasound-guided Technique

Intervention Type: PROCEDURE

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

Ultrasound Scan

Intervention Type: DEVICE

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

Interventions

PICC Placement by Landmark Technique

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

Intervention Type: PROCEDURE

PICC Placement by Ultrasound-guided Technique

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

Intervention Type: PROCEDURE

Ultrasound Scan

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

Equipo de Terapia Intravenosa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Montealegre, RN, IV Nurse

Role: STUDY_DIRECTOR

Hospital Universitario Clinico San Carlos

Other Identifiers

ETI-HCSC-01

Identifier Type: -

Identifier Source: org_study_id