Physical Restraints in Intensive Care Unit 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 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.

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