PICC PlacementPhase 3NCT02859987
Randomized Controlled Trial of Ultrasound-guided Versus Landmark Technique for Peripherally Inserted Central Catheter (PICC) Placement
A Phase 3 study testing PICC Placement by Landmark Technique, PICC Placement by Ultrasound-guided Technique and Ultrasound Scan in people with PICC Placement, run by Equipo de Terapia Intravenosa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PICC Placement
- What is being tested?
- PICC Placement by Landmark Technique, PICC Placement by Ultrasound-guided Technique and Ultrasound Scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- Patients with indication of PICC insertion for long-term intravenous therapy
Who cannot join
- Peripheral vascular disease
- Injecting drug users
About this study
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.
Read more
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
- Being tested
- PICC Placement by Landmark Technique, PICC Placement by Ultrasound-guided Technique, Ultrasound Scan
- Keywords
- US, Nursing Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC Placement by Landmark TechniqueProcedure or surgery
Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
PICC Placement by Ultrasound-guided TechniqueProcedure or surgery
Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
Ultrasound ScanDevice
Initially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement
| Study group | Role | What they receive |
|---|---|---|
| Landmark Technique | Active comparator | Blinded method for catheter placement Receives: Procedure: PICC Placement by Landmark Technique |
| Ultrasound-guided Technique | Experimental | Use sonography for catheter placement Receives: Procedure: PICC Placement by Ultrasound-guided Technique; Device: Ultrasound Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first 6 hours after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PICC PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equipo de Terapia Intravenosa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Carlos, Madrid
- Responsible party
- Sponsor
- Investigators
- Maria Montealegre, RN, IV Nurse, Study director, Hospital Universitario Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859987
- Sponsor's protocol ID
- ETI-HCSC-01
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Ultrasound-guided Versus Landmark Technique for Peripherally Inserted Central Catheter (PICC) Placement
- ClinicalTrials.gov ID
- NCT02859987
- Acronym / sponsor ID
- ETI-HCSC-01
- Conditions
- PICC Placement
- Keywords
- US, Nursing Services
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Equipo de Terapia IntravenosaUniversity, hospital or other
- Collaborators
- Hospital San Carlos, Madrid
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark Technique | Active comparator | Procedure: PICC Placement by Landmark TechniqueBlinded method for catheter placement |
| Ultrasound-guided Technique | Experimental | Procedure: PICC Placement by Ultrasound-guided Technique, Device: Ultrasound ScanUse sonography for catheter placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated informed consent.
- Patients with indication of PICC insertion for long-term intravenous therapy
Key exclusion criteria (2 listed)
- Peripheral vascular disease
- Injecting drug users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICC Placement by Landmark TechniqueComparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided) | Procedure or surgery | Landmark Technique |
| PICC Placement by Ultrasound-guided TechniqueComparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided) | Procedure or surgery | Ultrasound-guided Technique |
| Ultrasound ScanInitially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement | Device | Ultrasound-guided Technique |
Primary outcome
Evidence of catheter inserted at first attempt, correctly located (after chest X-ray performed) and proper working, confirmed by the nurse
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
Related trials for PICC Placement
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Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
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Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
Cancer Patients
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Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Montealegre, RN, IV Nurse study director
Hospital Universitario Clinico San Carlos
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PICC Placement by Landmark Technique, PICC Placement by Ultrasound-guided Technique and Ultrasound Scan in people with PICC Placement, run by Equipo de Terapia Intravenosa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of catheter inserted at first attempt, correctly located (after chest X-ray performed) and proper working, confirmed by the nurse (time frame: Within the first 6 hours after placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.