Cardiovascular Diseases3VNCT01685866
3V- Improve Venous Access in Pediatric Anesthesia
A study testing Vein-Viewer Vision in people with Cardiovascular Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Vein-Viewer Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to Mar 2014
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged less than 7
- DIVA score ≥ 4
- patient needing venous peripheral access for general anesthesia
Who cannot join
- no social security
- opposition of the parent(s) to the participation of their child in the trial
Trial locations and contacts
2 sites in 1 country.
France2 sites
Fondation ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
Robert Debré Hospital, APHP
Paris, Île-de-France Region, 75019
About this study
Official title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.
Read the detailed description
Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.
- Conditions
- Cardiovascular Diseases
- Being tested
- Vein-Viewer Vision
- Keywords
- anesthesia, venous access
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein-Viewer VisionDevice
A medical device called Vein-Viewer Vision
| Study group | Role | What they receive |
|---|---|---|
| Vein-Viewer Vision | Other | A medical device called Vein-Viewer Vision Receives: Device: Vein-Viewer Vision |
| no medical device | No intervention | in the second arm, we use no medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduce the time necessary to find the venous access during inhalation anesthesia induction
Measured: 1 day of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
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 Cardiovascular DiseasesStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Devys, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685866
- Sponsor's protocol ID
- SC/DM_JDS_2012-1_V1.0-20120605
- Acronym
- 3V
- Status last verified
- Aug 2014
- First submitted
- 12 Sep 2012
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.
PubMed 33606421
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
- ClinicalTrials.gov ID
- NCT01685866
- Acronym / sponsor ID
- 3V / SC/DM_JDS_2012-1_V1.0-20120605
- Conditions
- Cardiovascular Diseases
- Keywords
- anesthesia, venous access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Ministry of Health, France
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Sep 2012 (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.
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.
Detailed description
Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vein-Viewer Vision | Other | Device: Vein-Viewer VisionA medical device called Vein-Viewer Vision |
| no medical device | No intervention | –in the second arm, we use no medical device |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged less than 7
- DIVA score ≥ 4
- patient needing venous peripheral access for general anesthesia
Key exclusion criteria (2 listed)
- no social security
- opposition of the parent(s) to the participation of their child in the trial
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 |
|---|---|---|
| Vein-Viewer VisionA medical device called Vein-Viewer Vision | Device | Vein-Viewer Vision |
Primary outcome
reduce the time necessary to find the venous access during inhalation anesthesia induction
Time frame: 1 day of anesthesia
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 6 Aug 2014.
- Derived from this study: PubMed 33606421Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
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.
Jean-Michel Devys, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein-Viewer Vision in people with Cardiovascular Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
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 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
reduce the time necessary to find the venous access during inhalation anesthesia induction (time frame: 1 day of anesthesia). 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 NCT01685866, 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 6 Aug 2014.