AzTrials
AzTrials

Sickle Cell CrisisPERFIDNCT03477552

Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)

A study testing Accuvein V400 device and Routine procedure in people with Sickle Cell Crisis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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

The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sickle Cell Crisis
What is being tested?
Accuvein V400 device and Routine procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesFrance
Study dates
30 Mar 2018to 30 May 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sickle cell patients (all genotypes)
  • Patients hospitalized for uncomplicated vaso-occlusive crisis (CVO) in Internal/general Medicine department
  • Patients requiring the placement or replacement of a peripheral intra-venous catheter in the Department of Internal/general Medicine
  • Patients arrived in the internal/general medicine department of the hospital between 9h and 18h and except weekends
  • Signed informed consent.
  • Affiliated to the French health care insurance.

Who cannot join

  • Signs of shock
  • Acute chest Syndrome
  • Central venous catheter already present
  • Indication to have a central venous catheter from the ourset
  • Patient who has already participated to the PERFID study during the current hospitalization
  • Refusal of the patient's participation
  • Pregnant or lactating woman
  • Patient under guardianship or curatorship

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU H. Mondor

    Créteil

  • AP-HP - Hopital Europeen Georges-Pompidou Paris, France

    Paris, Île-de-France Region, 75908

Other trials in France

About this study

Official title: Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial

The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.

Being tested
Accuvein V400 device, Routine procedure
Keywords
Sickle Cell Crisis, intravenous catheter, transillumination
Medical subject headings
Vaso-Occlusive Crises

What participants receive

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

  • Accuvein V400 deviceDevice

    Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network

  • Routine procedureOther

    In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)

Study groups in NCT03477552
Study groupRoleWhat they receive
Accuvein V400 deviceExperimentalIn the Accuvein group, the nurse uses the Accuvein device to identify the veins before any puncture to infuse the patient and then proceeds as usual, under illumination of the device.
Receives: Device: Accuvein V400 device
Routine procedureActive comparatorIn the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Receives: Other: Routine procedure

What is being measured

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

  1. Number of venipunctures

    Number of venipunctures until the peripheral IV placement (with a retrograde blood sample) or before failure (discontinuation after at least 3 attempts by 2 nurses and a maximum of 9 attempts in total).

    Measured: Time of the infusion procedure

Secondary outcomes (11)

  1. Time of the procedure

    Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer

    Measured: Time of the infusion procedure

  2. Procedure failure

    Percentage of the procedure failure

    Measured: Time of the infusion procedure

  3. The need of a central venous catheter

    Percentage of use of a central venous catheter due to failure of peripheral perfusion.

    Measured: Time of the infusion procedure

  4. Patient bone pain before and after the procedure

    Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure

    Measured: Before and within 1 hour after a successful peripheral IV placement

  5. Anxiety before and after the procedure

    Patient and nurse anxiety will be evaluated by a visual 5 points-Likert scale (between 1=not at all anxiety to 5=extremely anxious) of anxiety before and after the procedure

    Measured: Just before and within 1 hour after a successful peripheral IV placement

  6. Patient satisfaction (pain)

    Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)

    Measured: Within 1 hour after a successful peripheral IV placement

  7. Patient satisfaction (procedure)

    Patient satisfaction of the procedure will be evaluated by a visual 5-points Likert scale (between 1=not at all anxiety to 5=extremely anxious) of satisfaction of the procedure

    Measured: Within 1 hour after a successful peripheral IV placement

  8. Nurse satisfaction (procedure)

    Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)

    Measured: Within 1 hour after a successful peripheral IV placement

  9. Nurse satisfaction (quality of placement)

    Nurse satisfaction of the quality of the peripheral intravenous placement will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)

    Measured: Within 1 hour after a successful peripheral IV placement

  10. Qualitative interview of the Accuvein use

    Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm

    Measured: An average of one week after the procedure

  11. Side effects of the procedure

    Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).

    Measured: Time of the infusion procedure

Timeline

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

  1. First posted26 Mar 2018
  2. Study start30 Mar 2018
  3. Primary completion30 Apr 2022
  4. Study completion30 May 2022

Resources

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
Adult sickle cell patients who need of a new peripheral intravenous catheter placement (for fluid or porphine therapy) will be randomized between two arms : usual technique or use of the AccuveinV400® device). The randomization list (ratio 1: 1) will be made by the statistician of the study using the SAS software and balanced by random blocks of small size (2, 4, 6) to make it unpredictable. The randomization will be stratified on the center and the number of hospitalizations in the previous year (\>3, \<3).
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477552
Sponsor's protocol ID
K160919J
Other IDs
2017-AO2746-47, PHRIP-16-0139
Acronym
PERFID
Status last verified
Jan 2023
First submitted
7 Feb 2018
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Corbasson A, Fischer E, Vilfaillot A, Da Costa AB, Charmettan M, Ferreira M, Barthelemy C, Namaoui W, Khimoud D, Beaudoin A, Berkani L, Guillaud C, Khellaf M, Flamarion E, Michon A, Lafont E, Cheminet G, Chatellier G, Pouchot J, Ranque B, Arlet JB. Efficacy of a vein visualisation device for facilitating peripheral venous line placement in adult patients with sickle cell disease: A randomised clinical trial. Int J Nurs Stud. 2025 Mar;163:104988. doi: 10.1016/j.ijnurstu.2024.104988. Epub 2024 Dec 19.

    PubMed 39787687

Questions about this trial

What is this clinical trial studying?

A study testing Accuvein V400 device and Routine procedure in people with Sickle Cell Crisis, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 8 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 13 Jan 2023. 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?

Number of venipunctures (time frame: Time of the infusion procedure). 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 NCT03477552, 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 13 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in