Clinical trial NCT04193540: Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
Official title: Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit Patient
Mechanical Ventilation
Sedatives
Decision-making Capacity
Confusion
Keywords: Intensive Care Unit patient
Mechanical Ventilation
Sedatives
Decision-making capacity
Confusion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
timeFrame: After inclusion
Secondary outcomes:
measure: Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient
timeFrame: : Immediately after inclusion and prior to Johns Hopkins ACE conduct
measure: ACE sub-items
timeFrame: Immediately after inclusion
measure: ICU length of stay
timeFrame: ICU discharge - Up to day 100
measure: Hospital length of stay
timeFrame: Hospital discharge - Up to day 200
measure: Ventilatory free days
timeFrame: Hospital discharge - Up to day 200
measure: Sedatives used within 72 hours before decision-making capacity evaluation
timeFrame: Within 72 hours before inclusion
measure: Analgesics used within 72 hours before decision-making capacity evaluation
timeFrame: Within 72 hours before inclusion
measure: Other molecules used within 72 hours before decision-making capacity evaluation
timeFrame: Within 72 hours before inclusion
measure: Sedatives used during decision-making capacity evaluation
timeFrame: During inclusion
measure: Analgesics used during decision-making capacity evaluation
timeFrame: During inclusion
measure: Other molecules used during decision-making capacity evaluation
timeFrame: During inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Thomas Godet
role: PRINCIPAL_INVESTIGATOR
References: