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Recruiting NCT05510401

Evaluation of Safe Use of SECURIDRAP® SELFIA®

No phase Interventional Disorientation Cognitive Impairment Behavior Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SECURIDRAP® SELFIA®.
Who it may be relevant to
Registry conditions: Disorientation, Cognitive Impairment, Behavior Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®

Overview

Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use. Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

Detailed description

The proposed study is a prospective, multicenter, interventional and non-comparative research.

This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.

This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.

The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.

Interventions

  • Other SECURIDRAP® SELFIA®
    Use of SECURIDRAP® SELFIA® for 15 night

Primary outcome measures

  • Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA® [Time frame: [15 days]]
Secondary outcome measures (4)
  • Rate of occurrence of user errors that could endanger patient safety [Time frame: [15 days]]
  • Rate of patients remaining bedridden each night for the duration of the sudy [Time frame: [15 days]]
  • Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient [Time frame: [15 days]]
  • The learning curve for using SECURIDRAP® SELFIA® by healthcare team [Time frame: [15 days]]

Eligibility criteria

Inclusion criteria

  • Patient at least 18 years old
  • Patient having a medical prescription for SÉCURIDRAP® SELFIA®
  • Patient in phase or state of disorientation
  • Patient with nocturnal behavior disordre
  • Patient with major cognitive impairment
  • Patient at risk of falling into bed
  • Patient subject to guardianship or curatorship
  • Patient beneficiary or affiliated to a social security scheme
  • Patient who has given their participation agreement aand informed consent

Exclusion criteria

  • Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
  • Patient in psychiatry
  • Patient with severe agitation
  • Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
  • Patient with intolerance to the medical device
  • Patient able to extract himself from SÉCURIDRAP® SELFIA®
  • Patient able to unlock the bed rails by himself
  • Patient without social coverage or not benefiting from it through a third party
  • Patient minor, pregnant woman, persons deprived of their liberty
  • Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 10 centers
  • CMMF de Bailleul — Bailleul
  • EHPAD l'Aquarelle — Bully-les-Mines
  • Centre Hospitalier d'Hazebrouck — Hazebrouck
  • Centre Hospitalier Le Quesnoy — Le Quesnoy
  • CHU Lille — Lille
  • Ussap- Asm Limoux — Limoux
  • CHU Lyon — Lyon
  • CHU Rennes — Rennes
  • … and 2 more centers

Identifiers

NCT: NCT05510401 · 2019-A03234-53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗