Success Rate for Subclavian or Femoral Vein CatetherisationNCT03207932
Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:
An observational study of Success Rate for Subclavian or Femoral Vein Catetherisation, run by University of Pisa at 1 site in Italy.
Trial summary
anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Success Rate for Subclavian or Femoral Vein Catetherisation
- What is being tested?
- Central vein catheterisation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2018to 10 Oct 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- Adult, Older adult
Study population: intensive care patients
Who may be able to join
- patients needing CVC
Who cannot join
- refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guidance Versus Anatomical Landmarks for Succlavic and Femoral Vein Catheterisation: an Observational Prospective Study
anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.
- Being tested
- Central vein catheterisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central vein catheterisationProcedure or surgery
ultrasound guided versus landmark central vein catheterisation
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | CVC insertion using ultrasound Receives: Procedure: Central vein catheterisation | |
| landmark technique | CVC insertion using landmark technique Receives: Procedure: Central vein catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt
success rate
Measured: during catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start10 May 2018
- Primary completion10 Jan 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Success Rate for Subclavian or Femoral Vein CatetherisationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Forfori, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207932
- Sponsor's protocol ID
- UPisa - subclavian/femoral
- Status last verified
- Nov 2020
- First submitted
- 2 Jul 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance Versus Anatomical Landmarks for Succlavic and Femoral Vein Catheterisation: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03207932
- Acronym / sponsor ID
- UPisa - subclavian/femoral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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.
anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound | – | Procedure: Central vein catheterisationCVC insertion using ultrasound |
| landmark technique | – | Procedure: Central vein catheterisationCVC insertion using landmark technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- intensive care patients
Key inclusion criteria (1 listed)
- patients needing CVC
Key exclusion criteria (1 listed)
- refusal of consent
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 |
|---|---|---|
| Central vein catheterisationultrasound guided versus landmark central vein catheterisation | Procedure or surgery | landmark technique, ultrasound |
Primary outcome
The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt
Time frame: during catheterization procedure
success rate
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 10 Nov 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Success Rate for Subclavian or Femoral Vein Catetherisation, run by University of Pisa at 1 site in Italy.
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 1 inclusion and 1 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt (time frame: during catheterization procedure). 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 10 Nov 2020.