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

Overview

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.

Full Title of Study: “Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

Interventions

  • 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
  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Number of venipunctures
    • Time Frame: Time of the infusion procedure
    • 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).

Secondary Measures

  • Time of the procedure
    • Time Frame: Time of the infusion procedure
    • Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer
  • Procedure failure
    • Time Frame: Time of the infusion procedure
    • Percentage of the procedure failure
  • The need of a central venous catheter
    • Time Frame: Time of the infusion procedure
    • Percentage of use of a central venous catheter due to failure of peripheral perfusion.
  • Patient bone pain before and after the procedure
    • Time Frame: Before and within 1 hour after a successful peripheral IV placement
    • Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure
  • Anxiety before and after the procedure
    • Time Frame: Just before and within 1 hour after a successful peripheral IV placement
    • 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
  • Patient satisfaction (pain)
    • Time Frame: Within 1 hour after a successful peripheral IV placement
    • Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)
  • Patient satisfaction (procedure)
    • Time Frame: Within 1 hour after a successful peripheral IV placement
    • 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
  • Nurse satisfaction (procedure)
    • Time Frame: Within 1 hour after a successful peripheral IV placement
    • Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
  • Nurse satisfaction (quality of placement)
    • Time Frame: Within 1 hour after a successful peripheral IV 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)
  • Qualitative interview of the Accuvein use
    • Time Frame: An average of one week after the procedure
    • Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm
  • Side effects of the procedure
    • Time Frame: Time of the infusion procedure
    • Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Benoit Arlet, MD,PhD, Principal Investigator, Medicine interne department, Europeen Georges Pompidou Hopital, Paris, France
    • Eric Fischer, Principal Investigator, Medicine interne department, Europeen Georges Pompidou Hospital, Paris, France
    • François Lionnet, MD, Principal Investigator, Medicine interne department, Tenon Hospital, Paris, France
  • Overall Contact(s)
    • Jean-Benoit Arlet, MD,PhD, 0033 1 56093331, jean-benoit.arlet@aphp.fr

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