Clinical trial NCT03477552: Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)
Official title: Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Crisis
Keywords: Sickle Cell Crisis
intravenous catheter
transillumination
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-03-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of venipunctures
timeFrame: Time of the infusion procedure
Secondary outcomes:
measure: Time of the procedure
timeFrame: Time of the infusion procedure
measure: Procedure failure
timeFrame: Time of the infusion procedure
measure: The need of a central venous catheter
timeFrame: Time of the infusion procedure
measure: Patient bone pain before and after the procedure
timeFrame: Before and within 1 hour after a successful peripheral IV placement
measure: Anxiety before and after the procedure
timeFrame: Just before and within 1 hour after a successful peripheral IV placement
measure: Patient satisfaction (pain)
timeFrame: Within 1 hour after a successful peripheral IV placement
measure: Patient satisfaction (procedure)
timeFrame: Within 1 hour after a successful peripheral IV placement
measure: Nurse satisfaction (procedure)
timeFrame: Within 1 hour after a successful peripheral IV placement
measure: Nurse satisfaction (quality of placement)
timeFrame: Within 1 hour after a successful peripheral IV placement
measure: Qualitative interview of the Accuvein use
timeFrame: An average of one week after the procedure
measure: Side effects of the procedure
timeFrame: Time of the infusion procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France
state: Ile-de-France
city: Créteil
country: France
facility: CHU H. Mondor
Study officials:
affiliation: Medicine interne department, Europeen Georges Pompidou Hopital, Paris, France
name: Jean-Benoit Arlet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicine interne department, Europeen Georges Pompidou Hospital, Paris, France
name: Eric Fischer
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicine interne department, Tenon Hospital, Paris, France
name: François Lionnet, MD
role: PRINCIPAL_INVESTIGATOR
References: