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

Sickle Cell Crisis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477552
• Other study ID #: K160919J
• Secondary ID: 2017-AO2746-47PH
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Crisis

Intervention

Device:
• Accuvein 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

Other:
• 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)

Locations

Country	Name	City	State
France	CHU H. Mondor	Créteil
France	AP-HP - Hopital Europeen Georges-Pompidou Paris, France	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Procedure failure	Percentage of the procedure failure	Time of the infusion procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Side effects of the procedure	Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).	Time of the infusion procedure