Physical Restraints in Intensive Care Unit Patients

Last updated: February 14, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Manic Disorders

Williams Syndrome

Treatment

ARBORea decision-making tool

Clinical Study ID

NCT04957238
PHRIP 2019 VIDAL
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient, male or female, over 18 years of age, hospitalized in ICU for at least 48hours.
  • Consent to participate in the patient's study or authorization to carry out theresearch collected from the designated trustworthy person (failing this, a familymember, or failing this, a close and stable relation with the person concerned)according to the modalities described in Title II of the book of the First PublicHealth Code. If no relative is present, the patient may be included on the advice ofthe investigator (article L. 1111-6). A consent form for continuation of the study anduse of the data will then be signed by the patient if and when the patient is againconscious and lucid, or if the patient is unable to express consent, authorization tocontinue the research will be obtained from the designated trusted person.
  • Patient covered by a social security system.

Exclusion

Exclusion Criteria:

  • Predictable and uninterrupted maintenance of deep sedation throughout the duration ofthe stay, due to the seriousness of the lesions, from the moment the patient isadmitted to the intensive care unit.
  • Lack of predictable remission of a severe coma present on admission to intensive care.
  • Refusal to participate by the patient, or by the trusted person contacted by default.
  • Patient with DNR (do not resuscitate) orders.
  • Patient under legal protection.
  • Patient already included in the protocol during another stay in resuscitation

Study Design

Total Participants: 4000
Treatment Group(s): 1
Primary Treatment: ARBORea decision-making tool
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
February 27, 2026

Study Description

Current study has been designed to measure the impact of an original tool intended to guide the decision to use physical restraints in ICU patients. In a multidisciplinary fashion, we have created a decision-making tool based on objective criteria in an attempt to reduce subjectivity that currently exists in this process of physical restraints use. This tool corresponds to a decision tree based on several criteria:

  • the RASS (Richmond Agitation-Sedation Scale) score that assesses patient's state of sedation and agitation. This neurological state could help to determine level of arousal possibly favorizing self-inflicted risks;

  • the existence of a delirious state (or delirium), assessed by the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit). This tool is used to detect and assess the presence of a delirium. In the case of a positive CAM-ICU, the patient presents a delirium and may therefore have unsuitable gestures;

  • the recent modification of pharmacological-induced sedation allows us to take into account a change in the dosage of infused sedation molecules in order to assess whether the patient may soon find himself in an awakening phase. This transitional phase makes patient's neurological state unstable and can lead to agitation and/or confusion;

  • the level of invasive equipment conditioning, defined by the type of device that equips the patient. Three levels of conditioning (C1, C2 and C3) have been defined, ranging from the least to the most harmful in the case of an unexpected removal:

    • Level C1 includes peripheral venous catheters, naso-gastric tubes and urinary catheters;

    • Level C2 includes endotracheal tube, central and arterial lines, renal replacement catheters, drains: thoracic, encephalic or abdominal; intracranial pressure sensors, Swan-Ganz catheters, redons, PICC (peripherally inserted central catheter) lines and Midlines;

    • Level C3 includes veno-venous and veno-arterial ECMO (extra-corporeal membrane oxygenation), intra-aortic counter-pulsion balloons and electro-systolic training probes;

  • the presence of patient's family and their adherence to his or her supervision. Families play a key role in patient's care. Their presence might sometimes soothe and reassure the patient. Their adherence and participation to patient's supervision may allow health care team to consider adequate compliance. Regular re-evaluation should then be carried out when they leave patient's room; In order to facilitate the work of caregivers, this decision-making tool has been transcribed into an electronic version that can be accessed online, on a tablet or a computer. Once the above criteria have been filled in, a proposal for whether or not to use physical restraints, as well as main variable criterion for reassessment of this use. This last criterion makes it possible to know the decisive factor that suggested the decision to use restraints or not.

In order to evaluate the impact of this tool on caregivers' decision to use physical restraints, three periods have been planned: a control period in order to evaluate actual practices, a period of training and implementation of the tool, so that each professional is rendered familiar with its use, and finally an intervention period during which the ARBORea tool will be used to suggest physical restraints use.

Connect with a study center

  • Centre Hospitalier d'Annecy

    Annecy,
    France

    Site Not Available

  • CH Henri Mondor

    Aurillac,
    France

    Active - Recruiting

  • Centre Hospitalier d'Avignon

    Avignon,
    France

    Active - Recruiting

  • Hôpital Nord Franche-Comté

    Belfort,
    France

    Active - Recruiting

  • Centre Hospitalier de Cergy-Pontoise

    Cergy-Pontoise,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Centre de Lutte Contre le Cancer Jean-Perrin

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Dijon

    Dijon,
    France

    Active - Recruiting

  • Centre Hospitalier du Puy en Velay

    Le Puy-en-Velay,
    France

    Active - Recruiting

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

    Lyon,
    France

    Active - Recruiting

  • Assistance Publique-Hôpitaux de Marseille - Hôpital Nord

    Marseille,
    France

    Site Not Available

  • Assistance Publique-Hôpitaux de Marseille - La Timone

    Marseille,
    France

    Active - Recruiting

  • Centre Hospitalier de Montluçon

    Montluçon,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Centre Hospitalier Moulins-Yzeure

    Moulins,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice,
    France

    Active - Recruiting

  • Hôpital de la Pitié Salpétrière

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier de Poissy

    Poissy,
    France

    Site Not Available

  • Centre Hospitalier de Rodez

    Rodez,
    France

    Site Not Available

  • CH de Saint Malo

    Saint-Malo,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Centre Hospitalier de Salon-de-Provence

    Salon-de-Provence,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale

    Strasbourg,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Strasbourg -MIR

    Strasbourg,
    France

    Active - Recruiting

  • Centre Hospitalier de Vichy

    Vichy,
    France

    Active - Recruiting

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