Randomized Controlled Trial of Ultrasound-guided Versus Landmark Technique for Peripherally Inserted Central Catheter (PICC) Placement
NCT02859987 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2016-08-11
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
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
Sponsors & Collaborators
-
Hospital San Carlos, Madrid
collaborator OTHER -
Equipo de Terapia Intravenosa
lead OTHER
Principal Investigators
-
Maria Montealegre, RN, IV Nurse · Hospital Universitario Clinico San Carlos
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2014-08-31
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