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ComplicationsLong&shortNCT01917253

Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation.

A study testing Standard Device for peripheral vein cannulation and Long Catheters for peripheral vein cannulation in people with Complications, run by ASL TO2 Torino at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Long and Short is a prospective, randomized, controlled, open label trial to test the complications of different device for peripheral vein cannulation, standard length (about 5 cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complications
What is being tested?
Standard Device for peripheral vein cannulation and Long Catheters for peripheral vein cannulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteItaly
Study dates
Sep 2013to Dec 2013
Phase
Interventional
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

  • adult patients
  • infusional therapy more than 72 hours

Who cannot join

  • need for central venous catheter

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • MECAU-Maria Vittoria Hospital

    Torino, Torino, 10141

    Piero Riva, MD, +39 011 439 ext. 3359

    Piero Riva, MD

    Recruiting

Other trials in Italy

About this study

Official title: Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation. A Randomized Controlled Clinical Trial to Test the Complications.

The Long and Short is a prospective, randomized, controlled, open label trial to test the complications of different device for peripheral vein cannulation, standard length (about 5 cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.

Read the detailed description

The trial will compare the main complications: infiltration rate, phlebitis rate, occlusion and/or dislocation rate, thrombosis rate, number of percutaneous sticks, successful cannulation.

Will be made for a cost analysis.

Conditions
Complications
Being tested
Standard Device for peripheral vein cannulation, Long Catheters for peripheral vein cannulation
Keywords
infiltration, phlebitis, occlusion, thrombosis
Medical subject headings
Phlebitis, Bites and Stings, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Device for peripheral vein cannulationDevice

  • Long Catheters for peripheral vein cannulationDevice

Study groups in NCT01917253
Study groupRoleWhat they receive
standard length catheterExperimentalStandard Device for peripheral vein cannulation
Receives: Device: Standard Device for peripheral vein cannulation
Long catheterExperimentalStandard Device for peripheral vein cannulation
Receives: Device: Long Catheters for peripheral vein cannulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complications rate

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917253
Sponsor's protocol ID
351/007A/2013
Acronym
Long&short
Status last verified
Aug 2013
First submitted
5 Aug 2013
Last updated
6 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Standard Device for peripheral vein cannulation and Long Catheters for peripheral vein cannulation in people with Complications, run by ASL TO2 Torino 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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tiziana De Prospo (+39 011 439 ext. 5739, tiziana.deprospo@aslto2.piemonte.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complications rate (time frame: 3 days). 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 6 Aug 2013.

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