This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.
Medicine has recently turned from paternalism to patient-centered decisions giving them back autonomy to determine their own treatments and end-of-life directives. Main prerequisite is patient's competence to fully understand information given from medical staff, integrate it and resituate comprehensive willing. Informed decision-making necessitates patient's ability to appropriately communicate and interact with its environment. Intensive care unit (ICU) patients are often intubated -rendering oral communication impossible- and get sedated with various medications (hypnotics and opioids). Despite an apparently appropriate communication, some of them are confused. Confusion is regularly under diagnosed in ICU settings and necessitates specific tools to be detected, such as CAM-ICU (Confusion Assessment Method in ICU). While not confused, a patient might lack decision-making capacity, meaning that despite obvious communication, more elaborated cognitive function remains uncertain and often inappropriate. Decision-making capacity can be evaluated with dedicated scores such as the Johns Hopkins adapted cognitive examination (ACE). This score has recently been formally translated into French. The influence of sedatives on decision-making capacity remains unknown to date. This prospective observational multicentre study is intended to investigate the impact of sedatives on the decision-making capacity of ICU patients. Furthermore, each sub-score of the ACE (orientation, language, registration, attention and calculation, and recall) will be investigated according to sedatives types. Patients' decision-making capacity will be clinically assessed by physician, resident and nurse in charge, blindly of ACE result.
Study Type
OBSERVATIONAL
Enrollment
500
Regardless of the result of the ACE questionnaire, physician, resident and nurse in charge of the patient will be asked their clinical opinion on decision-making capacity of the patient, based on a 4 steps Lickert scale and blindly of ACE result.
CHU
Clermont-Ferrand, France
RECRUITINGDecision-making capacity evaluated by Johns Hopkins ACE questionnaire
Global decision-making capacity is evaluated by Johns Hopkins ACE with a 3 groups classification (\< 29 severe alteration, 29-55: moderate alteration; \> 55 light alteration or normal cognitive function).
Time frame: After inclusion
Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient
Clinical determination of decision-making capacity of the patient blindly of Johns Hopkins ACE results
Time frame: : Immediately after inclusion and prior to Johns Hopkins ACE conduct
ACE sub-items
Decision-making capacity sub-items as determined by ACE (orientation, language, registration, attention and calculation, and recall)
Time frame: Immediately after inclusion
ICU length of stay
ICU length of stay
Time frame: ICU discharge - Up to day 100
Hospital length of stay
Hospital length of stay
Time frame: Hospital discharge - Up to day 200
Ventilatory free days
Ventilatory free days
Time frame: Hospital discharge - Up to day 200
Sedatives used within 72 hours before decision-making capacity evaluation
Sedatives administered to the patient within 72 hours before Johns Hopkins ACE will be collected (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
Time frame: Within 72 hours before inclusion
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Analgesics used within 72 hours before decision-making capacity evaluation
Analgesics administered to the patient within 72 hours before Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl)
Time frame: Within 72 hours before inclusion
Other molecules used within 72 hours before decision-making capacity evaluation
Other molecules administered to the patient within 72 hours before Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others)
Time frame: Within 72 hours before inclusion
Sedatives used during decision-making capacity evaluation
Sedatives administered to the patient during Johns Hopkins ACE will be (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
Time frame: During inclusion
Analgesics used during decision-making capacity evaluation
Analgesics administered to the patient during Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl
Time frame: During inclusion
Other molecules used during decision-making capacity evaluation
Other molecules administered to the patient during Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others
Time frame: During inclusion