Study Results
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Basic Information
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RECRUITING
NA
4000 participants
INTERVENTIONAL
2022-05-18
2026-02-27
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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ARBORea decision-making tool
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)
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.
Subjective physical restraints use
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Périne Vidal
Role: PRINCIPAL_INVESTIGATOR
CHU de Clermont-Ferrand
Locations
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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 de Montluçon
Montluçon, , 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
Countries
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Central Contacts
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Facility Contacts
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Simon CLUSE
Role: primary
Marie BONNEFOY
Role: primary
Nahila HIMER
Role: primary
Frédéric MOITRON
Role: primary
Christina TERON
Role: primary
Isabelle ROURE
Role: primary
Florian DEGIVRY
Role: primary
Jeremy Bourenne
Role: primary
Jeanne BOYER
Role: primary
Emilie DAVID
Role: primary
Nathalie REVEL
Role: primary
Claire FAZILLEAU
Role: primary
Sandrine PIOT
Role: primary
Mélika BERRAHAL
Role: primary
Maureen BOTHOREL
Role: primary
Coralie RIEHL
Role: primary
Sylvie L'HOTELLIER
Role: primary
Estelle MANTIN
Role: primary
References
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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.
Other Identifiers
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PHRIP 2019 VIDAL
Identifier Type: -
Identifier Source: org_study_id
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