Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04957238
NA

Physical Restraints in Intensive Care Unit Patients

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

Summary

The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients\' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload. In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation. Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events could urge caregivers to use physical restraints. Based on recent literature, about a third of ICU patients are restrained, and accidental deconditioning is mainly observed within these particular patients. In addition, three categories of patients have been defined according to the invasive nature of their equipment and therefore according to the risk associated with an unexpected withdrawal. Finally, presence of patient\'s family and their adherence to its surveillance were also implemented into the tool. Main study objective is to jointly investigate effectiveness and tolerance of a decision-making tool guiding physical restraints use in ICU patients.

Official title: Impact of a Decision-making Tool to Guide the Use of Physical Restraints in Intensive Care Unit Patients. A Multicentre Randomized Stepped-wedge Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4000

Start Date

2022-05-18

Completion Date

2026-02-02

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

OTHER

ARBORea decision-making tool

Online ARBORea decision-making tool will guide the use of physical restraints in ICU patients based on objective information on neurological status, level of equipment related to critical illness, and patient's family presence and involvement in patient's surveillance.

Locations (19)

CH Henri Mondor

Aurillac, France

Centre Hospitalier d'Avignon

Avignon, France

Hôpital Nord Franche-Comté

Belfort, France

Centre de Lutte Contre le Cancer Jean-Perrin

Clermont-Ferrand, France

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Centre Hospitalier Universitaire de Dijon

Dijon, France

Centre Hospitalier du Puy en Velay

Le Puy-en-Velay, France

Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, France

Assistance Publique-Hôpitaux de Marseille - La Timone

Marseille, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Centre Hospitalier Moulins-Yzeure

Moulins, France

Centre Hospitalier Universitaire de Nice

Nice, France

Hôpital de la Pitié Salpétrière

Paris, France

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

Centre Hospitalier de Salon-de-Provence

Salon-de-Provence, France

CH de Saint Malo

St-Malo, France

Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale

Strasbourg, France

Centre Hospitalier Universitaire de Strasbourg -MIR

Strasbourg, France

Centre Hospitalier de Vichy

Vichy, France