Clinical trial NCT04957238: Physical Restraints in Intensive Care Unit Patients
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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;
* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of physical restraints use (effectiveness)
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Rate of incidents (tolerance)
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
Secondary outcomes:
measure: Rate of incidents attributable to physical restraints use
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Rate of incidents without physical restraints use
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Characteristics of physical restraints
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Indications of physical restraints
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Rate of medically prescribed physical restraints
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Characteristics of recorded incidents
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Rate of recorded incidents
timeFrame: Day 0 up to the end of ICU stay, an average of 15 days
measure: Short Form Health Survey-36 (SF-36)
timeFrame: Three months after ICU discharge
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: Three months after ICU discharge
Other outcomes:
Locations:
city: Aurillac
country: France
facility: CH Henri Mondor
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Belfort
country: France
facility: Hôpital Nord Franche-Comté
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean-Perrin
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier du Puy en Velay
city: Lyon
country: France
facility: Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot
city: Marseille
country: France
facility: Assistance Publique-Hôpitaux de Marseille - La Timone
city: Montluçon
country: France
facility: Centre Hospitalier de Montluçon
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Moulins
country: France
facility: Centre Hospitalier Moulins-Yzeure
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Saint-Malo
country: France
facility: CH de Saint Malo
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Salon-de-Provence
country: France
facility: Centre Hospitalier de Salon-de-Provence
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg -MIR
city: Vichy
country: France
facility: Centre Hospitalier de Vichy
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Périne Vidal
role: PRINCIPAL_INVESTIGATOR
References: