Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.

Study Overview
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Brief Summary
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This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.

Detailed Description
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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.

Official Title
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Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.

Conditions
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Intensive Care Unit Patient, Mechanical Ventilation, Sedatives, Decision-making Capacity, Confusion

Intervention / Treatment
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* Other: ACE questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated patient (intubation or tracheotomy) Not delirious (negative CAM ICU) Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours Receiving sedatives and/or analgesics and/or medications interfering with neurological functions Adult patients with social security coverage Exclusion Criteria: Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest) Known cognitive disorders (MMSE < 20) Neurodegenerative disease Pregnant woman Protocol refusal by the patient or closest next-of-kin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACE questionnaire<br>Every patient under mechanical ventilation (intubated or tracheotomized), with or without sedatives, able to communicate and alert (RASS -1 to +1), and not delirious (CAM-ICU negative) will be assessed by Johns Hopkins ACE questionnaire by a person not in charge of the patient. | Other: ACE questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision-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). | After inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | : 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) | Immediately after inclusion | 
| ICU length of stay | ICU length of stay | ICU discharge - Up to day 100 | 
| Hospital length of stay | Hospital length of stay | Hospital discharge - Up to day 200 | 
| Ventilatory free days | Ventilatory free days | 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) | Within 72 hours before inclusion | 
| 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) | 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) | 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) | 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 | 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 | During inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit patient, Mechanical Ventilation, Sedatives, Decision-making capacity, Confusion