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CompletedNCT02859987Updated Aug 11, 2016

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

A Phase 3 interventional study of PICC Placement by Landmark Technique and PICC Placement by Ultrasound-guided Technique in PICC Placement, sponsored by Equipo de Terapia Intravenosa. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Equipo de Terapia Intravenosa · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • PICC Placement

Keywords

  • US
  • Nursing Services
03

In context

Lead sponsor

This is the only study on the registry with Equipo de Terapia Intravenosa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Peripheral vascular disease
  • Injecting drug users
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
199 participants (actual)

Study arms

  • Active comparator
    Landmark Technique

    Blinded method for catheter placement

    Procedure: PICC Placement by Landmark Technique

  • Experimental
    Ultrasound-guided Technique

    Use sonography for catheter placement

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

Interventions

  • ProcedurePICC Placement by Landmark Technique

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

  • ProcedurePICC Placement by Ultrasound-guided Technique

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

  • DeviceUltrasound Scan

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

06

What researchers measure

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

    Time frame: Within the first 6 hours after placement

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013 and a primary completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2016
First posted
Aug 9, 2016
Start
Aug 2013
Primary completionActual
Aug 2014
Last update
Aug 11, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02859987
Lead sponsor
Equipo de Terapia Intravenosa
Collaborators
Hospital San Carlos, Madrid
Responsible party
Sponsor
First posted
Aug 9, 2016
Start date
Aug 2013
Primary completion
Aug 2014
Last update
Aug 11, 2016

Study contacts

Maria Montealegre, RN, IV Nurse
study director · Hospital Universitario Clinico San Carlos
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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