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

Study Overview
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Brief Summary
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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
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PICC Placement

Intervention / Treatment
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* Procedure: PICC Placement by Landmark Technique
* Procedure: PICC Placement by Ultrasound-guided Technique
* Device: Ultrasound Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Landmark Technique<br>Blinded method for catheter placement | Procedure: PICC Placement by Landmark Technique<br>* Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)<br>|
| Experimental: Ultrasound-guided Technique<br>Use sonography for catheter placement | Procedure: PICC Placement by Ultrasound-guided Technique<br>* Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)<br>Device: Ultrasound Scan<br>* Initially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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US, Nursing Services