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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sickle Cell Crisis

Treatments: Other: Routine procedure; Device: Accuvein V400 device

Study type: Interventional

Funder types: Other

Identifiers

NCT03477552

PHRIP-16-0139 (Other Grant/Funding Number)

2017-AO2746-47 (Other Grant/Funding Number)

K160919J

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Accuvein V400 device

Experimental group

Description:

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.

Treatment:

Device: Accuvein V400 device

Routine procedure

Active Comparator group

Description:

In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)

Treatment:

Other: Routine procedure