Physical Restraints in Intensive Care Unit Patients (ARBORéa)
Critically Ill, Intensive Care Unit Delirium, Delirium Confusional State
About this trial
This is an interventional other trial for Critically Ill focused on measuring ICU, Physical restraints, Safety, Agitation, Delirium, Nursing care, Sedation, Family, Invasive devices
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
Sites / Locations
- Centre Hospitalier d'Annecy
- Centre Hospitalier d'Avignon
- Centre Hospitalier de Cergy-Pontoise
- Centre de Lutte Contre le Cancer Jean-Perrin
- Centre Hospitalier Universitaire de Clermont-FerrandRecruiting
- Centre Hospitalier Universitaire de Dijon
- Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot
- Assistance Publique-Hôpitaux de Marseille - Hôpital Nord
- Assistance Publique-Hôpitaux de Marseille - La Timone
- Centre Hospitalier de Montluçon
- Centre Hospitalier Universitaire de Montpellier
- Centre Hospitalier Universitaire de Nice
- Centre Hospitalier de Poissy
- Centre Hospitalier de Rodez
- Centre Hospitalier Universitaire de Saint-Etienne
- Centre Hospitalier de Salon-de-Provence
- Centre Hospitalier Universitaire de Strasbourg
- Centre Hospitalier de Vichy
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
ARBORea decision-making tool
Subjective physical restraints use
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, 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)
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.