Sickle Cell Crisis
Conditions
Keywords
Sickle Cell Crisis, intravenous catheter, transillumination
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.
Interventions
DEVICEAccuvein 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
OTHERRoutine procedure
In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Sponsors
Ministry of Health, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of venipunctures | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure failure | Time of the infusion procedure | Percentage of the procedure failure |
| The need of a central venous catheter | 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 | 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 | 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) | 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) |
| Time of the procedure | 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 |
| Nurse satisfaction (procedure) | 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) | 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 | 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 of the infusion procedure | Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise). |
| Patient satisfaction (procedure) | 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 |
Countries
France
Outcome results
None listed