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

NCT04226118 | Completed

• 1 other identifier: 69HCL19_0036
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients for whom peripheral venous access was performed from the first attempt.

  at time of peripheral venous access

Secondary Outcomes (4)

• 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

• 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)

Study Arms (2)

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.

Device: Vein Illumintion System device

Interventions

Vein Illumintion System device DEVICE

Spotting veins of a patient by use of a Vein Illumintion System device

Experimental Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

CRCM mixte de Giens

Giens, 83406, France

Location

Hôpital Nord - CRCM adulte Marseille

Marseille, 13015, France

Location

Hôpital enfant la Timone - CRCM pédiatrique Marseille

Marseille, 13385, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

Location

Hôpital Pasteur - CRCM adulte Nice

Nice, 06001, France

Location

Hôpital Lenval - CRCM pédiatrique Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 19, 2021
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

FR (6)