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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Crisis
• Intervention / Treatment: Device: Accuvein V400 device; Other: Routine procedure

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France
    • CHU H. Mondor
  • Ile-de-France
    • Paris, Ile-de-France, France, 75908
      • AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accuvein V400 device; 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; Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network
Active Comparator: Routine procedure; 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; In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time of the infusion procedure
Procedure failure	Percentage of the procedure failure	Time of the infusion procedure
The need of a central venous catheter	Percentage of use of a central venous catheter due to failure of peripheral perfusion.	Time of the infusion procedure
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	Before and within 1 hour after a successful peripheral IV placement
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	Just before and within 1 hour after a successful peripheral IV placement
Patient satisfaction (pain)	Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)	Within 1 hour after a successful peripheral IV placement
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	Within 1 hour after a successful peripheral IV placement
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)	Within 1 hour after a successful peripheral IV placement
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)	Within 1 hour after a successful peripheral IV placement
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	An average of one week after the procedure
Side effects of the procedure	Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).	Time of the infusion procedure

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: intravenous catheter; Sickle Cell Crisis; transillumination
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: K160919J; 2017-AO2746-47 (Other Grant/Funding Number: ANSM); PHRIP-16-0139 (Other Grant/Funding Number: Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes