Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older
Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract
 and the digestive system. Their management includes multi-year intravenous antibiotic
 treatments and repeated venous sampling. The venous access is a source of difficulties that
 nurses who take care of these patients face on a daily basis. In addition, multiple attempts
 at punctures can induce anxiety and pain in patients. It is therefore important to limit
 failures.

 Vein visualization technologies exist: guidance echo, portable trans lumination or infrared
 visualization can guide venipuncture and limit failures.

 Compared with the guided echo or the portable trans lumination, the infrared visualization is
 easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this
 technique are few in chronic diseases and mainly conducted in young children.

 This study aims to show that the use of a vein illumination system (VIS) should improve the
 peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent
 and adult patients with cystic fibrosis, and improve comfort of the patient (pain,
 apprehension of the gesture).
Background :

 Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract
 and the digestive system. Their management includes multi-year intravenous antibiotic
 treatments and repeated venous sampling. The venous access is a source of difficulties that
 nurses who take care of these patients face on a daily basis. In addition, multiple attempts
 at punctures can induce anxiety and pain in patients. It is therefore important to limit
 failures.

 Vein visualization technologies exist: guidance echo, portable trans lumination or infrared
 visualization can guide venipuncture and limit failures.

 Compared with the guided echo or the portable trans lumination, the infrared visualization is
 easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this
 technique are few in chronic diseases and mainly conducted in young children.

 This study aims to show that the use of a vein illumination system (VIS) should improve the
 peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent
 and adult patients with cystic fibrosis, and improve comfort of the patient (pain,
 apprehension of the gesture).

 Objectives of the study :

 The main objective of the study is to demonstrate that the use of a vein illumination system
 (VIS) for the placement of a peripheral venous line or venous sampling on the hand, forearm
 or fold of the elbow improves peripheral venous access (PVA) successful on the first attempt.

 The secondary objectives are :

 -  To study the efficacy of VIS for peripheral venous access (placement of a peripheral
 venous line or peripheral venous sampling in the hand, forearm or elbow) on the number
 of attempts.

 -  To study the impact of the use of SIV on the patient's pain felt during the peripheral
 venous access procedure.

 -  To study the impact of VIS on patient anxiety prior to peripheral venous access.

 -  To describe the nurses and nursing students satisfaction with the use of the VIS device
 for peripheral venous access.

 -  To study the determinants of the success of peripheral venous access at the first
 attempt among the characteristics of nurses and nursing students (age, year of obtaining
 their diploma, experience within the cystic fibrosis ressource and competence center).

 -  To describe the nurses and nursing students satisfaction with the use of A-DIVA scale.

 Study design The study will last 36 months. It is an open and randomized multicenter cluster
 study, with sequential allocation of the device (stepped wedge allocation), comparing a group
 of patients benefiting from a technique of locating the puncture site by a venous
 illumination system for a peripheral venoux access (hand, forearm, fold of the elbow) to a
 group of patients whose veins are identified according to the usual modality of a peripheral
 venoux access. The cluster is defined by the Cystic Fibrosis Resource and Competence Center
 (CRCM).

 Expected results

 For the patients, the use of a venous illumination system device during the peripheral venous
 access should facilitate the success of the gesture on the first attempt, allowing to :

 -  Reduce their pain due to multiple attempts.

 -  Reduce their anxiety associated with peripheral venous access.

 -  Preserve their venous capital This could have an impact on their care, such as making it
 easier to consult for them and being less anxious about peripheral venous access.

 For the nurses, using a venous illimunation system device could

 -  Reduce their apprehension of peripheral venous access gesture

 -  Save their time with fewer peripheral venous access are repeated. It is considered that
 this technique will be distributed to all Cytic Fibrosis Ressource and Competence
 Centers (CRCM) in order to improving the comfort of the chronically ill patient with
 repeated blood tests and intravenous treatments.
Inclusion Criteria:

 -  Patients with cystic fibrosis aged 12 years and over

 -  Cystic Fibrosis diagnosis has been confirmed by a positive sweat test and/or 1 to 2
 genetic mutations

 -  Patients requiring peripheral venous access (hand, forearm, or more of the elbow) for
 intravenous infusion with epicranial or short catheter, or for a blood sample

 -  Patients who have a score of 4 or higher on the A-DIVA scale (self-administered
 questionnaire completed by the IDE assessing the difficulty of peripheral venous
 access on a Likert scale from 0 to 8)

 -  Patients informed in writing of the terms of the study and provided written informed
 consent to participate (consent of the person in charge of parental authority if the
 patient is a minor).

 -  Patients affiliated to a social security system

 Exclusion Criteria:

 -  Patient who has already participated in the study

 -  Patients who have a central venous approach

 -  Patients who have a venous approach of the midline type

 -  Patients taken care of for vital emergency

 -  Patient deprived of liberty or placed under tutorship or curatorship