Physical Restraints in Intensive Care Unit Patients

Critically Ill Clinical Trial

— ARBORéa  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957238
• Other study ID #: PHRIP 2019 VIDAL
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: February 27, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33 4 73 754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: February 27, 2026
• Est. primary completion date: November 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Confusion
• Critical Illness
• Critically Ill
• Delirium
• Delirium Confusional State
• Intensive Care Unit Delirium
• Psychomotor Agitation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	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-Étienne
France	CH de Saint Malo	Saint-Malo
France	Centre Hospitalier de Salon-de-Provence	Salon-de-Provence
France	Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale	Strasbourg
France	Centre Hospitalier Universitaire de Strasbourg -MIR	Strasbourg
France	Centre Hospitalier de Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Day 0 up to the end of ICU stay, an average of 15 days
Secondary	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.	Three months after ICU discharge
Secondary	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.	Three months after ICU discharge