Clinical trial NCT05510401: Evaluation of Safe Use of SECURIDRAP® SELFIA®
Official title: Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorientation
Cognitive Impairment
Behavior Disorders
Keywords: disorientation
nocturnal behavioral disorders
major cognitive impairment
Lead sponsor: Groupe Mulliez-Flory
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-08-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-comparative clinical investigation
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
timeFrame: [15 days]
Secondary outcomes:
measure: Rate of occurrence of user errors that could endanger patient safety
timeFrame: [15 days]
measure: Rate of patients remaining bedridden each night for the duration of the sudy
timeFrame: [15 days]
measure: Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient
timeFrame: [15 days]
measure: The learning curve for using SECURIDRAP® SELFIA® by healthcare team
timeFrame: [15 days]
Other outcomes:
Locations:
city: Bailleul
country: France
facility: CMMF de Bailleul
city: Bully-les-Mines
country: France
facility: EHPAD l'Aquarelle
city: Hazebrouck
country: France
facility: Centre Hospitalier d'Hazebrouck
city: Le Quesnoy
country: France
facility: Centre Hospitalier Le Quesnoy
city: Lille
country: France
facility: CHU Lille
city: Limoux
country: France
facility: Ussap- Asm Limoux
city: Lyon
country: France
facility: CHU Lyon
city: Rennes
country: France
facility: CHU Rennes
city: Roubaix
country: France
facility: CHG Roubaix
city: Saint Jean Delnous
country: France
facility: CSSR La Clauze
Study officials:
affiliation: CHU Lille
name: François Pr PUISIEUX
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Aline Dr CORVOL
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Sabine Dr AHMINE
role: PRINCIPAL_INVESTIGATOR
affiliation: CSSR La Clauze
name: Thierry Dr LECRIQUE
role: PRINCIPAL_INVESTIGATOR
affiliation: USSAP- ASM LIMOUX
name: Brigitte Dr GERS
role: PRINCIPAL_INVESTIGATOR
affiliation: USSAP- ASM LIMOUX
name: Marguerite Dr REY
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD l'Aquarelle
name: Valérie Dr WIEL
role: PRINCIPAL_INVESTIGATOR
affiliation: CMMF de Bailleul
name: Brigitte Dr TILMONT
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Hazebrouck
name: Eddy Dr BAHEU
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Le Quesnoy
name: Denis Dr LEFEBVRE
role: PRINCIPAL_INVESTIGATOR
affiliation: CSSR La Clauze
name: Philippe Dr VEAU
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG Roubaix
name: Pearlide Dr Kizonzolo-de-Bello
role: PRINCIPAL_INVESTIGATOR
References: