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

Assistance Publique - Hôpitaux de Paris126 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

126

Conditions

Sickle Cell Crisis

Interventions

Accuvein V400 device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHU H. Mondor

Créteil, France

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

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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 frame: Time of the infusion procedure

Secondary Outcomes

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 frame: Time of the infusion procedure

Procedure failure

Percentage of the procedure failure

Time frame: 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 frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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 frame: Time of the infusion procedure