Physical Restraints in Intensive Care Unit Patients

NCT04957238 | Recruiting DMC

• 1 other identifier: PHRIP 2019 VIDAL
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Critically Ill; Intensive Care Unit Delirium; Delirium Confusional State; Agitation,Psychomotor

Keywords

ICU; Physical restraints; Safety; Agitation; Delirium; Nursing care; Sedation; Family; Invasive devices

Outcome Measures

Primary Outcomes (2)

• Rate of physical restraints use (effectiveness)

  Effectiveness is defined as the rate of observations with the use of restraints; statistical unit will be observations per patient (measured at least every 8 hours) over the entire duration of the ICU stay.

  Day 0 up to the end of ICU stay, an average of 15 days

• Rate of incidents (tolerance)

  Tolerance is defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-ablation of C2 conditioning, a fall, or self- or hetero-aggressive behaviour. Incidents are determined as soon as an incident occurs, measured every day during ICU stay.

  Day 0 up to the end of ICU stay, an average of 15 days

Secondary Outcomes (9)

• Rate of incidents attributable to physical restraints use

  Day 0 up to the end of ICU stay, an average of 15 days

• Rate of incidents without physical restraints use

  Day 0 up to the end of ICU stay, an average of 15 days

• Characteristics of physical restraints

  Day 0 up to the end of ICU stay, an average of 15 days

• Indications of physical restraints

  Day 0 up to the end of ICU stay, an average of 15 days

• Rate of medically prescribed physical restraints

  Day 0 up to the end of ICU stay, an average of 15 days

Study Arms (2)

ARBORea decision-making tool

EXPERIMENTAL

After a period of presentation and training on the dedicated decision-making tool (face-to-face, video and paper supports), nurses will be asked to use ARBORéa decision tree. This will be in the form of an electronic file and will give a suggestion of whether or not to use physical restraints. This is based on an algorithm based on specific and mandatory elements (neurological state : RASS (Richmond assessment sedation scale) and CAM-ICU (confusion assessment method-ICU) scores, modification of sedation dosage, equipment levels, presence and adhesion of the family) that will be completed online. ARBORea's suggestion will be collected as well as final caregiver's decision in order to evaluate relevance of the tool. Observations will also be made at least every 8 hours. This period will also be of random duration (stepped wedge)

Other: ARBORea decision-making tool

Subjective physical restraints use

NO INTERVENTION

After study presentation and required data collection description, nurses will complete elements related to ARBORea's tool variables, and inform their actual practices of physical restraints use, at least every 8 hours. ARBORea data concern patient's neurological state (RASS and CAM-ICU scores) and changes in sedation doses. The conditioning will then be filled in to stratify the risk incurred. Pain management will be notified. Finally, the presence and involvement of the families will be collected. Other data, relating to working conditions of the nurses will be collected: nurse to patient ratio, special and time consuming events (new patient admission, in ICU emergencies, need to conduct a patient to CT-scan facility or operative room, change of patient's equipment). Nurse seniority in ICU will be specified. Incidents that have occurred (fall, self-injury, removal of a level C2 equipment). The random duration of this control period will be determined by stepped wedge sequencing.

Interventions

ARBORea decision-making tool OTHER

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.

ARBORea decision-making tool

Eligibility Criteria

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

You may qualify if:

• Patient, male or female, over 18 years of age, hospitalized in ICU for at least 48 hours.
• Consent to participate in the patient's study or authorization to carry out the research collected from the designated trustworthy person (failing this, a family member, 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 Public Health Code. If no relative is present, the patient may be included on the advice of the investigator (article L. 1111-6). A consent form for continuation of the study and use of the data will then be signed by the patient if and when the patient is again conscious and lucid, or if the patient is unable to express consent, authorization to continue the research will be obtained from the designated trusted person.
• Patient covered by a social security system.

You may not qualify if:

• Predictable and uninterrupted maintenance of deep sedation throughout the duration of the stay, due to the seriousness of the lesions, from the moment the patient is admitted 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (20)

CH Henri Mondor

Aurillac, France

RECRUITING

Centre Hospitalier d'Avignon

Avignon, France

RECRUITING

Hôpital Nord Franche-Comté

Belfort, France

RECRUITING

Centre de Lutte Contre le Cancer Jean-Perrin

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, France

RECRUITING

Centre Hospitalier du Puy en Velay

Le Puy-en-Velay, France

RECRUITING

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

Lyon, France

RECRUITING

Assistance Publique-Hôpitaux de Marseille - La Timone

Marseille, France

RECRUITING

Centre Hospitalier de Montluçon

Montluçon, France

WITHDRAWN

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

RECRUITING

Centre Hospitalier Moulins-Yzeure

Moulins, France

RECRUITING

Centre Hospitalier Universitaire de Nice

Nice, France

RECRUITING

Hôpital de la Pitié Salpétrière

Paris, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

RECRUITING

Centre Hospitalier de Salon-de-Provence

Salon-de-Provence, France

RECRUITING

CH de Saint Malo

St-Malo, France

RECRUITING

Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale

Strasbourg, France

RECRUITING

Centre Hospitalier Universitaire de Strasbourg -MIR

Strasbourg, France

RECRUITING

Centre Hospitalier de Vichy

Vichy, France

RECRUITING

Related Publications (1)

• Vidal P, Lambert C, Pereira B, Martinez R, Araujo L, Yakhni M, Rolhion C, Morand D, Cosserant S, Genes I, Godet T, Barage A; ARBORea Collaborative group. Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol. BMJ Open. 2025 May 21;15(5):e085674. doi: 10.1136/bmjopen-2024-085674.

  PMID: 40398949 DERIVED

MeSH Terms

Conditions

Critical Illness; Confusion; Psychomotor Agitation; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Neurocognitive Disorders; Mental Disorders

Study Officials

• Périne Vidal

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: July 12, 2021
• Study Start: May 18, 2022
• Primary Completion: November 27, 2025
• Study Completion: February 27, 2026
• Last Updated: February 15, 2024

Record last verified: 2023-09

Locations

FR (20)