Evaluation of Safe Use of SECURIDRAP® SELFIA®

Sponsor

Groupe Mulliez-Flory (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05510401

Collaborator

EVAMED (Other)

108

Enrollment

Location

Arm

7.5

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorientation Cognitive Impairment Behavior Disorders	Other: SECURIDRAP® SELFIA®	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

non-comparative clinical investigationnon-comparative clinical investigation

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 18, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: SECURIDRAP® SELFIA® Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor	Other: SECURIDRAP® SELFIA® Use of SECURIDRAP® SELFIA® for 15 night

Arm

Intervention/Treatment

Other: SECURIDRAP® SELFIA®

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

Other: SECURIDRAP® SELFIA®

Use of SECURIDRAP® SELFIA® for 15 night

Outcome Measures

Primary Outcome Measures

Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA® [[15 days]]
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

Secondary Outcome Measures

Rate of occurrence of user errors that could endanger patient safety [[15 days]]
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
Rate of patients remaining bedridden each night for the duration of the sudy [[15 days]]
P = [(NNL)/ (NU)] x 100 with: NNL : the number of nights , patient has not released NU : the number of use; (number of overnight stays)
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]]
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
The learning curve for using SECURIDRAP® SELFIA® by healthcare team [[15 days]]
The curve reflects the time required for nursing expertise in the use of SECURIDRAP.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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