Requiring Subclavian Vein CannulationPhase 2/3SUBGEUSNCT01888094

SUBclavian Central Venous Catheters Guidance and Examination by UltraSound

A Phase 2/3 study testing Ultrasound-guided cannulation and examination in people with Requiring Subclavian Vein Cannulation and Adult Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Requiring Subclavian Vein Cannulation, Adult Patients, Patient Covered by French Health Care System
What is being tested?: Ultrasound-guided cannulation and examination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteFrance
Study dates: Jun 2013to Dec 2015
Phase: Phase 2/3
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

adults patients
requiring subclavian vein cannulation
patient covered by french health care system

Who cannot join

patient refusal
requiring vein cannulation femoral or jugular
we see nothing with echocardiography
children and not adult patients

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Clermont-Ferrand
Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method

Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

Read the detailed description

One groupe : Ultrasound guided for cannulation and examination of absence ofcomplications One groupe : landmark method and examination with chest radiography

Conditions: Requiring Subclavian Vein Cannulation, Adult Patients, Patient Covered by French Health Care System
Being tested: Ultrasound-guided cannulation and examination
Keywords: Central venous catheter, Complications, Ultrasound, Subclavian vein cannulation, Critical care, Echocardiography, Chest radiographyiography

What participants receive

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

Ultrasound-guided cannulation and examinationOther

Study groups in NCT01888094
Study group	Role	What they receive
ultrasound guided for cannulation and examination	Experimental	Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound Receives: Other: Ultrasound-guided cannulation and examination
landmark method and examination with chest radiography	Other	Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound Receives: Other: Ultrasound-guided cannulation and examination

What is being measured

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

procedure time between the beginning of procedure ( TO) and when the catheter is controlled ( T4) between strategy catheter cannulation 'standard' and a strategy called "ultrasound all
Measured: at day 1

Secondary outcomes (4)

procedure time Tn-Tn (n 0-5) between the two strategies.
Measured: at day 1
incidence of occurrence of complications: pneumothorax, hemothorax, bad positioning (outside of the superior vena cava or the right atrium) between the two strategies
Measured: at day 1
failure of technology between the two strategies.
Measured: at day 1
occurrence of central venous catheter infection.
Measured: at day 1

Timeline

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

Jun 2013Dec 2015

First posted27 Jun 2013 (estimated)
Study startJun 2013
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Requiring Subclavian Vein CannulationStudies of the same condition, open and under way.
More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01888094
Sponsor's protocol ID: CHU-0159
Acronym: SUBGEUS
Status last verified: Jun 2016
First submitted: 25 Jun 2013
Last updated: 27 Jun 2016
Results posted: No

Publications

Perbet S, Pereira B, Grimaldi F, Duale C, Bazin JE, Constantin JM. Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:175. doi: 10.1186/1745-6215-15-175.
PubMed 24885789

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method
ClinicalTrials.gov ID: NCT01888094
Acronym / sponsor ID: SUBGEUS / CHU-0159
Conditions: Requiring Subclavian Vein Cannulation, Adult Patients, Patient Covered by French Health Care System
Keywords: Central venous catheter, Complications, Ultrasound, Subclavian vein cannulation, Critical care, Echocardiography, Chest radiographyiography
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: University Hospital, Clermont-FerrandUniversity, hospital or other
Study start: Jun 2013
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 Jun 2013 (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.

Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

Detailed description

One groupe : Ultrasound guided for cannulation and examination of absence ofcomplications One groupe : landmark method and examination with chest radiography

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ultrasound guided for cannulation and examination	Experimental	Other: Ultrasound-guided cannulation and examinationProspective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound
landmark method and examination with chest radiography	Other	Other: Ultrasound-guided cannulation and examinationProspective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

adults patients
requiring subclavian vein cannulation
patient covered by french health care system

Key exclusion criteria (4 listed)

patient refusal
requiring vein cannulation femoral or jugular
we see nothing with echocardiography
children and not adult patients

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
Ultrasound-guided cannulation and examination	Other	landmark method and examination with chest radiography, ultrasound guided for cannulation and examination

Primary outcome

procedure time between the beginning of procedure ( TO) and when the catheter is controlled ( T4) between strategy catheter cannulation 'standard' and a strategy called "ultrasound all
Time frame: at day 1

4 secondary outcomes

procedure time Tn-Tn (n 0-5) between the two strategies.
Time frame: at day 1
incidence of occurrence of complications: pneumothorax, hemothorax, bad positioning (outside of the superior vena cava or the right atrium) between the two strategies
Time frame: at day 1
failure of technology between the two strategies.
Time frame: at day 1
occurrence of central venous catheter infection.
Time frame: at day 1

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 27 Jun 2016.
Derived from this study: PubMed 24885789Perbet S, Pereira B, Grimaldi F, Duale C, Bazin JE, Constantin JM. Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:175. doi: 10.1186/1745-6215-15-175.

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.

Sébastien PERBET principal investigator

University Hospital, Clermont-Ferrand

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 27 Jun 2016. 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 France. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

procedure time between the beginning of procedure ( TO) and when the catheter is controlled ( T4) between strategy catheter cannulation 'standard' and a strategy called "ultrasound all (time frame: at day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888094, which also lists 1 linked publication.

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 27 Jun 2016.