Obesity, MorbidAccuVNCT03555864
Intravenous Access Using Infrared Laser
An observational study of Obesity, Morbid and Obstetric Anesthesia Problems, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index > 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity, Morbid, Obstetric Anesthesia Problems
- What is being tested?
- infrared transluminescent device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2017to 4 Jul 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that need second intravenous access for surgery or obstetric
Who may be able to join
- > 18 years
- surgery that need double intravenous perfusion
Who cannot join
- < 18 years
- body mass index< 35
- refusal
- minor surgery that need only one intravenous access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Intravenous Cannulation With Support of Infrared Laser Vein Viewing System in Obese Patients
Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index > 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).
- Conditions
- Obesity, Morbid, Obstetric Anesthesia Problems
- Being tested
- infrared transluminescent device
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared transluminescent deviceDevice
use of infra red for venous access for second intravenous access
| Study group | Role | What they receive |
|---|---|---|
| Obese | Patients need two intravenous access with infra red Receives: Device: infrared transluminescent device |
What is being measured
The primary outcome is the main question the study is designed to answer.
success for second intravenous line using infra red
number of attempts
Measured: 1 day
Secondary outcomes (1)
time
time in second for second intravenous access
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start6 Nov 2017
- Primary completion30 Nov 2018
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
- Investigators
- jean-yves Lefrant, MD,PhD, Study chair, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555864
- Sponsor's protocol ID
- Local-PC-2017-2
- Acronym
- AccuV
- Status last verified
- Jul 2019
- First submitted
- 30 Dec 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Intravenous Cannulation With Support of Infrared Laser Vein Viewing System in Obese Patients
- ClinicalTrials.gov ID
- NCT03555864
- Acronym / sponsor ID
- AccuV / Local-PC-2017-2
- Conditions
- Obesity, Morbid, Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 14 Jun 2018 (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.
Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index > 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Device: infrared transluminescent devicePatients need two intravenous access with infra red |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that need second intravenous access for surgery or obstetric
Key inclusion criteria (2 listed)
- > 18 years
- surgery that need double intravenous perfusion
Key exclusion criteria (4 listed)
- < 18 years
- body mass index< 35
- refusal
- minor surgery that need only one intravenous access
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 |
|---|---|---|
| infrared transluminescent deviceuse of infra red for venous access for second intravenous access | Device | Obese |
Primary outcome
success for second intravenous line using infra red
Time frame: 1 day
number of attempts
1 secondary outcome
time
Time frame: 1 day
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
jean-yves Lefrant, MD,PhD study chair
Centre Hospitalier Universitaire de Nīmes
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 Obesity, Morbid and Obstetric Anesthesia Problems, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 2 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 8 Jul 2019. 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.
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?
success for second intravenous line using infra red (time frame: 1 day). 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 8 Jul 2019.