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

Phase 3

Completed

• Conditions: PICC Placement
• Interventions: Procedure: PICC Placement by Ultrasound-guided Technique; Procedure: PICC Placement by Landmark Technique; Device: Ultrasound Scan

• Registration Number: NCT02859987
• Lead Sponsor: Equipo de Terapia Intravenosa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-08
• Status Verified: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided Technique	PICC Placement by Ultrasound-guided Technique	Use sonography for catheter placement
Ultrasound-guided Technique	Ultrasound Scan	Use sonography for catheter placement
Landmark Technique	PICC Placement by Landmark Technique	Blinded method for catheter placement

Primary Outcome Measures

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