An interventional study of ARBORea decision-making tool in Critically Ill, Intensive Care Unit Delirium and Delirium Confusional State, sponsored by University Hospital, Clermont-Ferrand. Completed at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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.
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 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:
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.
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Exclusion Criteria:
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, pain assessment and the presence of analgesics, 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
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.
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.
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.
Time frame: 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.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
All-cause mortality.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of incidents attributable to physical restraints use
Deterioration or removal of C2 conditioning, falls, self- or hetero-aggression. As soon as an incident occurs, measured every day during ICU stay.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of incidents without physical restraints use
Non-restraint incident rates for all levels of conditioning. As soon as an incident occurs, measured every day during ICU stay.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Characteristics of physical restraints
Typology (upper limbs, lower limbs or abdominal) of the physical restraints performed, in controlled and innovative situations. At least once every 8 hours, during ICU stay, an average of 15 days.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Indications of physical restraints
Described indications of the physical restraints performed, in controlled and innovative situations. At least once every 8 hours, during ICU stay, an average of 15 days.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of medically prescribed physical restraints
Number of restraints prescribed in relation to the number of total restraints. At least once every 8 hours, during ICU stay, an average of 15 days.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Characteristics of recorded incidents
Description of incidents recorded, in controlled and innovative situations. The main types of incidents that can occur are deconditioning, falls, self or hetero aggression. As soon as an incident occurs, measured every day during ICU stay, an average of 15 days.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of recorded incidents
Rate of incidents recorded, in controlled and innovative situations. The main types of incidents that can occur are deconditioning, falls, self- or hetero-aggressivity, among others. As soon as an incident occurs, measured every day during ICU stay, an average of 15 days.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Short Form Health Survey-36 (SF-36)
Medical outcomes study (SF-36) is a survey that include 36 questions to evaluate patients' quality of life. The result of the questionnaire varies from 0 to 100. A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.
Time frame: Three months after ICU discharge
Impact of Event Scale - Revised (IES-R)
Impact of Event Scale - Revised, is a survey to assess the presence of post-traumatic stress symptoms. It includes 22 items. The total IES-R score is calculated by adding the values obtained for the 22 items (scores 0-88). A score above 22 indicates the presence of acute stress, if the score is above 36 it indicates the presence of post traumatic stress.
Time frame: Three months after ICU discharge
Delirium-free days (DFDs) to 28 days following inclusion.
A DFD is defined as the absence of delirium (absence of CAM-ICU positive) within a 24-hour period.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
ICU-free days (censored at 28 days following inclusion)
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Duration of ICU and hospital stay
Patients who will be outside the hospital but in other types of healthcare facilities at day 28 will be considered to have been discharged home.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
All-cause mortality to day 90 following ICU discharge.
Time frame: To day 90 following ICU discharge.
Time to death (or censoring).
Time frame: Day 0 up to the end of ICU stay or to day 90 following ICU discharge.
Plan to share: Undecided — Individual participant data will be shared upon reasonable request, and after steering committee deliberation.
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University Hospital, Clermont-Ferrand