Evaluation of Safe Use of SECURIDRAP® SELFIA®

NCT05510401 | Recruiting

• 1 other identifier: 2019-A03234-53
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 10

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.

Conditions

Disorientation; Cognitive Impairment; Behavior Disorders

Keywords

disorientation; nocturnal behavioral disorders; major cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®

  quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used

  [15 days]

Secondary Outcomes (4)

• Rate of occurrence of user errors that could endanger patient safety

  [15 days]

• Rate of patients remaining bedridden each night for the duration of the sudy

  [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

  [15 days]

• The learning curve for using SECURIDRAP® SELFIA® by healthcare team

  [15 days]

Study Arms (1)

SECURIDRAP® SELFIA®

OTHER

Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor

Other: SECURIDRAP® SELFIA®

Interventions

SECURIDRAP® SELFIA® OTHER

Use of SECURIDRAP® SELFIA® for 15 night

SECURIDRAP® SELFIA®

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Mulliez-Flory: lead
• EVAMED: collaborator

Study Sites (10)

CMMF de Bailleul

Bailleul, France

RECRUITING

EHPAD l'Aquarelle

Bully-les-Mines, France

RECRUITING

Centre Hospitalier d'Hazebrouck

Hazebrouck, France

RECRUITING

Centre Hospitalier Le Quesnoy

Le Quesnoy, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Ussap- Asm Limoux

Limoux, France

RECRUITING

CHU Lyon

Lyon, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHG Roubaix

Roubaix, France

RECRUITING

CSSR La Clauze

Saint-Jean-Delnous, France

RECRUITING

MeSH Terms

Conditions

Confusion; Cognitive Dysfunction; Mental Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders

Study Officials

• François Pr PUISIEUX

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Aline Dr CORVOL

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Sabine Dr AHMINE

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Thierry Dr LECRIQUE

  CSSR La Clauze

  PRINCIPAL INVESTIGATOR

• Brigitte Dr GERS

  USSAP- ASM LIMOUX

  PRINCIPAL INVESTIGATOR

• Marguerite Dr REY

  USSAP- ASM LIMOUX

  PRINCIPAL INVESTIGATOR

• Valérie Dr WIEL

  EHPAD l'Aquarelle

  PRINCIPAL INVESTIGATOR

• Brigitte Dr TILMONT

  CMMF de Bailleul

  PRINCIPAL INVESTIGATOR

• Eddy Dr BAHEU

  CH Hazebrouck

  PRINCIPAL INVESTIGATOR

• Denis Dr LEFEBVRE

  CH Le Quesnoy

  PRINCIPAL INVESTIGATOR

• Philippe Dr VEAU

  CSSR La Clauze

  PRINCIPAL INVESTIGATOR

• Pearlide Dr Kizonzolo-de-Bello

  CHG Roubaix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline BETOUX

CONTACT

0241637810; c.betoux@mulliez-flory.fr

Kelly LAVERGNE

CONTACT

0231932118; kelly.lavergne@evamed.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-comparative clinical investigation

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: August 22, 2022
• Study Start: May 18, 2022
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)