Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)
- Conditions
- Sickle Cell Crisis
- Interventions
- Other: Routine procedureDevice: Accuvein V400 device
- Registration Number
- NCT03477552
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine procedure 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) Accuvein V400 device 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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)
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
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
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)
Side effects of the procedure Time of the infusion procedure Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).
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
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
Procedure failure Time of the infusion procedure Percentage of the procedure failure
Trial Locations
- Locations (2)
AP-HP - Hopital Europeen Georges-Pompidou Paris, France
🇫🇷Paris, Ile-de-France, France
CHU H. Mondor
🇫🇷Créteil, France