Evaluation of Safe Use of SECURIDRAP® SELFIA®

Study Overview
=================
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.

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

Conditions
-----------------
Disorientation, Cognitive Impairment, Behavior Disorders

Intervention / Treatment
-----------------
* Other: SECURIDRAP® SELFIA®


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: non-comparative clinical investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SECURIDRAP® SELFIA®<br>Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor | Other: SECURIDRAP® SELFIA®<br>* Use of SECURIDRAP® SELFIA® for 15 night<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of user errors that could endanger patient safety | These usage errors will be measured during the verification of correct use of the SÉCURIDRAP® SELFIA® by the independent assessor, 2 hours after patient has been installed in the medical device | [15 days] | 
| Rate of patients remaining bedridden each night for the duration of the sudy | P = [(NNL)/ (NU)] x 100 with: NNL : the number of nights , patient has not released NU : the number of use; (number of overnight stays) | [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 saving for healthcare teams via a graduated scale of 0-10 The weel-being / comfort of the patient via a graduated scale of 0-10 Respect for the dignity of the patient via a graduated scale of 0-10 | [15 days] | 
| The learning curve for using SECURIDRAP® SELFIA® by healthcare team | The curve reflects the time required for nursing expertise in the use of SECURIDRAP. | [15 days] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disorientation, nocturnal behavioral disorders, major cognitive impairment