EmergenciesPREVENTNCT04628975
PeRfusion Emergency VEiNlite Transillumination
A study testing transillumination dispositif in people with Emergencies and Toxicomania, run by Central Hospital, Nancy, France.
Trial summary
When taking care of an emergency patient (Emergency Reception Service: UAS and Urgent Medical Assistance Service: SAMU), the installation of a peripheral venous route (VVP) is an important step. The benchmark method is the most widely used technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Toxicomania, Hypotension
- What is being tested?
- transillumination dispositif
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >= 18 years old
- extrem body mass index
- hypotension
- toxicomania
- limited ponction site
- hypotherm patient
Show all 9Show fewer
- dehydrated patient
- generalized edema
- non-supportive environment
Who cannot join
- parturient / pregnant female / breastfeeding mother
- unemancipated minor
- adults under legal protection
- person under judicial protection, guardianship or curatorship
Trial locations and contacts
No sites are listed yet.
Catherine Staszewski contact
About this study
Official title: Evaluation of the Efficacy of Transillumination on Peripheral Venous Line Placement in Patients With a Difficult Vascular Approach Who Are Managed in the Emergency Department.
When taking care of an emergency patient (Emergency Reception Service: UAS and Urgent Medical Assistance Service: SAMU), the installation of a peripheral venous route (VVP) is an important step. The benchmark method is the most widely used technique. This vascular access will allow the necessary therapy to be delivered quickly and efficiently. This can be difficult and sometimes doomed to failure for reasons related both to the patient (venous capital not very visible / felt or limited due to the profile of the patient), or sometimes also for reasons related to the patient. environment (limited lighting, difficult patient access). The only current alternatives lie in the use of a device such as the Intra-Bone Device (IID) or the installation of a central venous line. On the other hand, these alternatives are particularly invasive and / or very algogenic.
There are other techniques, which are more affordable and "transportable" outside the hospital. Indeed, trans-illumination with a very short training seems to be a particularly interesting alternative. It allows, thanks to LEDs in contact with the skin, to backlight the superficial veins.
Read more
It is proposed through this project to evaluate this tool for a category of patients considered "difficult" to infuse, both within hospital and outside hospital.
The main objective of the study is to assess the effectiveness of the transillumination device, compared to the absence of such a device, on the placement of a peripheral venous line (PVP) in patients with a difficult vascular approach and managed in the emergency room and whose clinical condition does not require the installation of an intraosseous device.
This is a multicenter, prospective, controlled, randomized and open clinical study, according to a cross-over design. The intervention evaluated is the placement of a PVR using the trans-illumination device. The control intervention is the placement of a PVR without this device, according to the reference method, which is the benchmark method.
400 patients presenting to the emergency room will be included in the centers of Nancy, Toul and Pont-à-Mousson.
Depending on their randomization group, nurses will perform peripheral venous insertion by the transillumination method or by the control method.
- Conditions
- Emergencies, Toxicomania, Hypotension, Obesity, Cachexia, Hypothermia
- Being tested
- transillumination dispositif
- Keywords
- adult, peripheral venous approach, emergency, transillumation
- Medical subject headings
- Emergencies, Hypotension, Obesity, Cachexia, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transillumination dispositifDevice
infrared light
| Study group | Role | What they receive |
|---|---|---|
| with transillumination | Experimental | The nurses will use the Transillumination method for a period P1. Then these same nurses will use the control method (without transillumination) for a period P2. Receives: Device: transillumination dispositif |
| without transillumination (control method) | No intervention | The nurses will use the control method for a period P1. Then these same nurses will use the Transillumination method for a period P2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
Measured: immediately after procedure
Secondary outcomes (4)
number of attempts before successful venous line placement
Measured: during the procedure
patient pain
The patient's pain is measured by the digital pain scale (scale ranging from 0 (no pain) to 10 (intolerable pain)).
Measured: during the procedure
nurse stress
Nurse stress is measured by the digital stress scale (scale ranging from 0 (no stress) to 10 (intolerable stress)).
Measured: during the procedure
The caliber of the peripheral venous route
measured by the type of catheter gauge used
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-center prospective randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Staszewski, Principal investigator, CH Pont à Mousson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628975
- Sponsor's protocol ID
- 2020-A00891-38
- Acronym
- PREVENT
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Transillumination on Peripheral Venous Line Placement in Patients With a Difficult Vascular Approach Who Are Managed in the Emergency Department.
- ClinicalTrials.gov ID
- NCT04628975
- Acronym / sponsor ID
- PREVENT / 2020-A00891-38
- Conditions
- Emergencies, Toxicomania, Hypotension, Obesity, Cachexia, Hypothermia
- Keywords
- adult, peripheral venous approach, emergency, transillumation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 16 Nov 2020 (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.
When taking care of an emergency patient (Emergency Reception Service: UAS and Urgent Medical Assistance Service: SAMU), the installation of a peripheral venous route (VVP) is an important step. The benchmark method is the most widely used technique. This vascular access will allow the necessary therapy to be delivered quickly and efficiently. This can be difficult and sometimes doomed to failure for reasons related both to the patient (venous capital not very visible / felt or limited due to the profile of the patient), or sometimes also for reasons related to the patient. environment (limited lighting, difficult patient access). The only current alternatives lie in the use of a device such as the Intra-Bone Device (IID) or the installation of a central venous line. On the other hand, these alternatives are particularly invasive and / or very algogenic.
There are other techniques, which are more affordable and "transportable" outside the hospital. Indeed, trans-illumination with a very short training seems to be a particularly interesting alternative. It allows, thanks to LEDs in contact with the skin, to backlight the superficial veins.
It is proposed through this project to evaluate this tool for a category of patients considered "difficult" to infuse, both within hospital and outside hospital.
The main objective of the study is to assess the effectiveness of the transillumination device, compared to the absence of such a device, on the placement of a peripheral venous line (PVP) in patients with a difficult vascular approach and managed in the emergency room and whose clinical condition does not require the installation of an intraosseous device.
This is a multicenter, prospective, controlled, randomized and open clinical study, according to a cross-over design. The intervention evaluated is the placement of a PVR using the trans-illumination device. The control intervention is the placement of a PVR without this device, according to the reference method, which is the benchmark method.
400 patients presenting to the emergency room will be included in the centers of Nancy, Toul and Pont-à-Mousson.
Depending on their randomization group, nurses will perform peripheral venous insertion by the transillumination method or by the control method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-center prospective randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| with transillumination | Experimental | Device: transillumination dispositifThe nurses will use the Transillumination method for a period P1. Then these same nurses will use the control method (without transillumination) for a period P2. |
| without transillumination (control method) | No intervention | –The nurses will use the control method for a period P1. Then these same nurses will use the Transillumination method for a period P2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >= 18 years old
- extrem body mass index
- hypotension
- toxicomania
- limited ponction site
Key exclusion criteria (4 listed)
- parturient / pregnant female / breastfeeding mother
- unemancipated minor
- adults under legal protection
- person under judicial protection, guardianship or curatorship
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 |
|---|---|---|
| transillumination dispositifinfrared light | Device | with transillumination |
Primary outcome
Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
Time frame: immediately after procedure
4 secondary outcomes
number of attempts before successful venous line placement
Time frame: during the procedure
patient pain
Time frame: during the procedure
nurse stress
Time frame: during the procedure
The caliber of the peripheral venous route
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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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.
Catherine Staszewski contact
Catherine Staszewski principal investigator
CH Pont à Mousson
Questions about this trial
What is this clinical trial studying?
A study testing transillumination dispositif in people with Emergencies and Toxicomania, run by Central Hospital, Nancy, 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 9 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Julie Lecomte (0383155278, ju.lecomte@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients for whom peripheral venous vein placement was successful on the first attempt (time frame: immediately after 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 16 Nov 2020.