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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 :
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 :
For the nurses, using a venous illimunation system device could
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients who have a peripheral venous access by a classic procedure, without using a Vein Illumination System. | |
| Experimental Group | Experimental | Patients who have a peripheral venous access by a procedure using a Vein Illumination System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vein Illumintion System device | Device | Spotting veins of a patient by use of a Vein Illumintion System device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients for whom peripheral venous access was performed from the first attempt. | at time of peripheral venous access |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts to place a peripheral venous line or perform peripheral venous | at time of peripheral venous access | |
| Average pain score on Visual Analogue Scale (VAS) after successful peripheral venous access act. | at most 10 min after the venous act |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRCM mixte de Giens | Giens | 83406 | France | |||
| Hôpital Nord - CRCM adulte Marseille |
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| Average anxiety score on State-Trait Anxiety Inventory (STAI-Y) | at most 10 min before the venous act |
| Proportion of nurses and nursing student satisfied by the use of a vein illumination system | at the end of the study ( at 14 months) |
| Marseille |
| 13015 |
| France |
| Hôpital enfant la Timone - CRCM pédiatrique Marseille | Marseille | 13385 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34090 | France |
| Hôpital Pasteur - CRCM adulte Nice | Nice | 06001 | France |
| Hôpital Lenval - CRCM pédiatrique Nice | Nice | 06202 | France |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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