Critically IllARBORéaNCT04957238
Physical Restraints in Intensive Care Unit Patients
A study testing ARBORea decision-making tool in people with Critically Ill and Intensive Care Unit Delirium, run by University Hospital, Clermont-Ferrand at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Intensive Care Unit Delirium, Delirium Confusional State
- What is being tested?
- ARBORea decision-making tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 19 sitesFrance
- Study dates
- 18 May 2022to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CH Henri Mondor
Aurillac
Centre Hospitalier d'Avignon
Avignon
Hôpital Nord Franche-Comté
Belfort
Centre de Lutte Contre le Cancer Jean-Perrin
Clermont-Ferrand
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand
Centre Hospitalier Universitaire de Dijon
Dijon
Centre Hospitalier du Puy en Velay
Le Puy-en-Velay
Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon
Assistance Publique-Hôpitaux de Marseille - La Timone
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
Centre Hospitalier Moulins-Yzeure
Moulins
Centre Hospitalier Universitaire de Nice
Nice
Hôpital de la Pitié Salpétrière
Paris
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne
Centre Hospitalier de Salon-de-Provence
Salon-de-Provence
CH de Saint Malo
St-Malo
Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale
Strasbourg
Centre Hospitalier Universitaire de Strasbourg -MIR
Strasbourg
Centre Hospitalier de Vichy
Vichy
About this study
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.
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.
Read more
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.
Read the detailed 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;
- pain assessment and the presence of analgesics. Pain can also be the cause of patient agitation.
- 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
- Critically Ill, Intensive Care Unit Delirium, Delirium Confusional State, Agitation,Psychomotor
- Being tested
- ARBORea decision-making tool
- Keywords
- ICU, Physical restraints, Safety, Agitation, Delirium, Nursing care, Sedation, Family, Invasive devices
- Medical subject headings
- Critical Illness, Confusion, Psychomotor Agitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARBORea decision-making toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 up to the end of ICU stay, an average of 15 days
All-cause mortality.
Measured: Day 0 up to the end of ICU stay, an average of 15 days
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 up to the end of ICU stay, an average of 15 days
ICU-free days (censored at 28 days following inclusion)
Measured: 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.
Measured: Day 0 up to the end of ICU stay, an average of 15 days
All-cause mortality to day 90 following ICU discharge.
Measured: To day 90 following ICU discharge.
Time to death (or censoring).
Measured: Day 0 up to the end of ICU stay or to day 90 following ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start18 May 2022
- Primary completion8 Dec 2025
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Périne Vidal, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957238
- Sponsor's protocol ID
- PHRIP 2019 VIDAL
- Acronym
- ARBORéa
- Status last verified
- Sep 2024
- First submitted
- 11 Mar 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be shared upon reasonable request, and after steering committee deliberation.
Publications
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.
PubMed 40398949
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04957238
- Acronym / sponsor ID
- ARBORéa / PHRIP 2019 VIDAL
- Conditions
- Critically Ill, Intensive Care Unit Delirium, Delirium Confusional State, Agitation,Psychomotor
- Keywords
- ICU, Physical restraints, Safety, Agitation, Delirium, Nursing care, Sedation, Family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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;
- pain assessment and the presence of analgesics. Pain can also be the cause of patient agitation.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARBORea decision-making tool | Experimental | Other: ARBORea decision-making toolAfter 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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARBORea decision-making toolOnline 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. | Other | ARBORea decision-making tool |
Primary outcome
Rate of physical restraints use (effectiveness)
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
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.
Rate of incidents (tolerance)
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
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.
All-cause mortality.
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
14 secondary outcomes
Rate of incidents attributable to physical restraints use
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of incidents without physical restraints use
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Characteristics of physical restraints
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Indications of physical restraints
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of medically prescribed physical restraints
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Characteristics of recorded incidents
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Rate of recorded incidents
Time frame: Day 0 up to the end of ICU stay, an average of 15 days
Short Form Health Survey-36 (SF-36)
Time frame: Three months after ICU discharge
Impact of Event Scale - Revised (IES-R)
Time frame: Three months after ICU discharge
Delirium-free days (DFDs) to 28 days following inclusion.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 40398949Vidal 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.
- Individual participant dataSharing planned: Undecided. Individual participant data will be shared upon reasonable request, and after steering committee deliberation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Périne Vidal principal investigator
University Hospital, Clermont-Ferrand
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARBORea decision-making tool in people with Critically Ill and Intensive Care Unit Delirium, run by University Hospital, Clermont-Ferrand at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of physical restraints use (effectiveness) (time frame: Day 0 up to the end of ICU stay, an average of 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04957238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.