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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sickle Cell Crisis

Intervention / Treatment
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* Device: Accuvein V400 device
* Other: Routine procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle Cell Crisis, intravenous catheter, transillumination