Vascular AccessAVEnNCT03427723
Accuvein Versus Standard Care for Intravenous Cannulation Procedure in Children
A study testing Accuvein®400 in people with Vascular Access, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Peripheral intravenous cannulation is one of the most common procedures performed in children admitted to hospital. It is a painful and anxiety-provoking gesture for children with possible memorization of the pain even more present for patients with chronic pathology. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Vascular Access
- What is being tested?
- Accuvein®400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 1 Feb 2020
- 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 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child under 3 years old (male or female) managed at the University Hospital of Clermont-Ferrand with an indication of the placement of a peripheral intravenous access,
- Represented by a person having parental authority,
- Parents or holder of parental authority capable of giving their consent to the study.
Who cannot join
- Need for urgent medical care
- Care practiced by a student nurse or pediatric nurse
- Refusal of the child or the holder of parental authority.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Etienne MERLIN
About this study
Official title: Peripheral Intravenous Cannulation in Children With Difficult Vein Access : Randomized Study Comparing Accuvein®400 Versus Standard Care
Peripheral intravenous cannulation is one of the most common procedures performed in children admitted to hospital. It is a painful and anxiety-provoking gesture for children with possible memorization of the pain even more present for patients with chronic pathology. Nevertheless, this care is essential to administer the treatments.
The cannulation is usually set up by the observation and touching of the veins by the nurse. However, this technique is often insufficient in young children and especially infants because they have a higher thickness adipose tissue. Their veins are of small caliber, hardly visible and palpable which increases the probability of a failure of the insertion of the catheter at the first attempt.
Read more
In the literature, different techniques are mentioned to promote the visualization of veins and thus the insertion of cannulation. The AccuVein®400 (AV400) system uses an infrared laser beam to project the image of superficial veins to the skin. In adults, AV400 has been shown to improve the success rate of insertion cannulation when venous capital is precarious. The question now arises as to whether this tool could be of interest to children who are particularly difficult to assist cannulation, especially the youngest of them.
Investigator hypothesize that AV400 could bring a benefit to the placement of cannulation, in the child with a venous capital difficult to catheterize and thus increase the success of the cannulation at the first attempt.
Read the detailed description
Children admitted to pediatric emergencies, pediatric day hospitals and the general pediatric ward, who are less than 3 years old and whose care requires the placement of a cannulation will be identified by the caregivers as potentially included.
The DIVA score will be carried out by the nurse who takes care of the child thanks to the dedicated form. If the child has an Emla® patch, this score will be achieved after removing the patch. The nurse that will achieve the score will be the same that will pose the intravenous cannulation. Children with an assessment score <4 will not be included in the study but will still be counted.
The nurse must perform the randomization by inquiring about the randomization week: standard method or AV400 method.
The information will be made to the parents and the information form given. The parents' consent regarding the care of their child will be collected by the same nurse.
The means of prevention of pain and distraction will be set up in box with the nurse and / or the auxiliary childcare and the parents. Peripheral intravenous cannulation will be performed by the nurse in collaboration with the auxiliary childcare.
Caregivers and parents will evaluate the care. The documents concerning the practical realization of the study will be grouped together and made available in each service in dedicated bins.
- Conditions
- Vascular Access
- Being tested
- Accuvein®400, Standard care
- Keywords
- Peripheral intravenous cannulation, children, near-infrared light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuvein®400Device
The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation
Standard careOther
The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | visualization and palpation Receives: Other: Standard care |
| Accuvein | Experimental | system uses an infrared laser beam to project the image of superficial veins to the skin Receives: Device: Accuvein®400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful of cannulation at first attempt
Percentage of children whose peripheral intravenous cannulation, at first attempt, is successful.
Measured: At day 1 (at the moment of peripheral intravenous cannulation)
Secondary outcomes (4)
Time required to install peripheral intravenous cannulation with AV400 and with the standard method
time in minute for peripheral intravenous cannulation
Measured: at day 1 (at the moment of peripheral intravenous cannulation)
effectiveness of the care by the nurse and the parents thanks
Score regarding the effectiveness of the care by the nurse and the parents thanks to the Lickert scale 5 points (from "not convinced at all" to "very convinced")
Measured: at day 1 (at the moment of peripheral intravenous cannulation)
pain assessment during insertion intravenous cannulation
Score regarding pain during insertion intravenous cannulation by an hetero scale of pain assessment : FLACC (Face Legs Activity Cry Consolability). Validated scale for acute pain during a care for children from 0 to 7 years
Measured: at day 1 (at the moment of peripheral intravenous cannulation)
Success rate according to the cannulation installation site
percentage of successful of cannulation according to the cannulation installation site
Measured: at day 1 (at the moment of peripheral intravenous cannulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start31 Jan 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- accuvein versus standard
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MERLIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427723
- Sponsor's protocol ID
- CHU-374
- Other IDs
- 2017-A02975-49
- Acronym
- AVEn
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Intravenous Cannulation in Children With Difficult Vein Access : Randomized Study Comparing Accuvein®400 Versus Standard Care
- ClinicalTrials.gov ID
- NCT03427723
- Acronym / sponsor ID
- AVEn / CHU-374
- Conditions
- Vascular Access
- Keywords
- Peripheral intravenous cannulation, children, near-infrared light
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 9 Feb 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 intravenous cannulation is one of the most common procedures performed in children admitted to hospital. It is a painful and anxiety-provoking gesture for children with possible memorization of the pain even more present for patients with chronic pathology. Nevertheless, this care is essential to administer the treatments.
The cannulation is usually set up by the observation and touching of the veins by the nurse. However, this technique is often insufficient in young children and especially infants because they have a higher thickness adipose tissue. Their veins are of small caliber, hardly visible and palpable which increases the probability of a failure of the insertion of the catheter at the first attempt.
In the literature, different techniques are mentioned to promote the visualization of veins and thus the insertion of cannulation. The AccuVein®400 (AV400) system uses an infrared laser beam to project the image of superficial veins to the skin. In adults, AV400 has been shown to improve the success rate of insertion cannulation when venous capital is precarious. The question now arises as to whether this tool could be of interest to children who are particularly difficult to assist cannulation, especially the youngest of them.
Investigator hypothesize that AV400 could bring a benefit to the placement of cannulation, in the child with a venous capital difficult to catheterize and thus increase the success of the cannulation at the first attempt.
Detailed description
Children admitted to pediatric emergencies, pediatric day hospitals and the general pediatric ward, who are less than 3 years old and whose care requires the placement of a cannulation will be identified by the caregivers as potentially included.
The DIVA score will be carried out by the nurse who takes care of the child thanks to the dedicated form. If the child has an Emla® patch, this score will be achieved after removing the patch. The nurse that will achieve the score will be the same that will pose the intravenous cannulation. Children with an assessment score <4 will not be included in the study but will still be counted.
The nurse must perform the randomization by inquiring about the randomization week: standard method or AV400 method.
The information will be made to the parents and the information form given. The parents' consent regarding the care of their child will be collected by the same nurse.
The means of prevention of pain and distraction will be set up in box with the nurse and / or the auxiliary childcare and the parents. Peripheral intravenous cannulation will be performed by the nurse in collaboration with the auxiliary childcare.
Caregivers and parents will evaluate the care. The documents concerning the practical realization of the study will be grouped together and made available in each service in dedicated bins.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- accuvein versus standard
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard carevisualization and palpation |
| Accuvein | Experimental | Device: Accuvein®400system uses an infrared laser beam to project the image of superficial veins to the skin |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child under 3 years old (male or female) managed at the University Hospital of Clermont-Ferrand with an indication of the placement of a peripheral intravenous access,
- Represented by a person having parental authority,
- Parents or holder of parental authority capable of giving their consent to the study.
Key exclusion criteria (3 listed)
- Need for urgent medical care
- Care practiced by a student nurse or pediatric nurse
- Refusal of the child or the holder of parental authority.
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 |
|---|---|---|
| Accuvein®400The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation | Device | Accuvein |
| Standard careThe intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation | Other | Standard care |
Primary outcome
successful of cannulation at first attempt
Time frame: At day 1 (at the moment of peripheral intravenous cannulation)
Percentage of children whose peripheral intravenous cannulation, at first attempt, is successful.
4 secondary outcomes
Time required to install peripheral intravenous cannulation with AV400 and with the standard method
Time frame: at day 1 (at the moment of peripheral intravenous cannulation)
effectiveness of the care by the nurse and the parents thanks
Time frame: at day 1 (at the moment of peripheral intravenous cannulation)
pain assessment during insertion intravenous cannulation
Time frame: at day 1 (at the moment of peripheral intravenous cannulation)
Success rate according to the cannulation installation site
Time frame: at day 1 (at the moment of peripheral intravenous cannulation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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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.
Etienne MERLIN 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?
A study testing Accuvein®400 in people with Vascular Access, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 3 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 9 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful of cannulation at first attempt (time frame: At day 1 (at the moment of peripheral intravenous cannulation)). 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 9 Feb 2018.