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

NCT03477552 | Completed FDA Device

• 3 other identifiers: K160919J2017-AO2746-47PHRIP-16-0139
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Sickle Cell Crisis

Keywords

Sickle Cell Crisis; intravenous catheter; transillumination

Outcome Measures

Primary Outcomes (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).

  Time of the infusion procedure

Secondary Outcomes (11)

• Time of the procedure

  Time of the infusion procedure

• Procedure failure

  Time of the infusion procedure

• The need of a central venous catheter

  Time of the infusion procedure

• Patient bone pain before and after the procedure

  Before and within 1 hour after a successful peripheral IV placement

• Anxiety before and after the procedure

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

Study Arms (2)

Accuvein V400 device

EXPERIMENTAL

In 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.

Device: Accuvein V400 device

Routine procedure

ACTIVE COMPARATOR

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

Other: Routine procedure

Interventions

Accuvein V400 device DEVICE

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

Accuvein V400 device

Routine procedure OTHER

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

Routine procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (2)

CHU H. Mondor

Créteil, France

Location

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

Paris, Île-de-France Region, 75908, France

Location

Related Publications (1)

• 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.

  PMID: 39787687 DERIVED

MeSH Terms

Conditions

Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean-Benoit Arlet, MD,PhD

  Medicine interne department, Europeen Georges Pompidou Hopital, Paris, France

  PRINCIPAL INVESTIGATOR

• Eric Fischer

  Medicine interne department, Europeen Georges Pompidou Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

• François Lionnet, MD

  Medicine interne department, Tenon Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 26, 2018
• Study Start: March 30, 2018
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)