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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 15, 2020

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.

Interventions

  • Other: ACE questionnaire
    • 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.

Arms, Groups and Cohorts

  • ACE questionnaire
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Decision-making capacity evaluated by Johns Hopkins ACE questionnaire
    • Time Frame: After inclusion
    • 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).

Secondary Measures

  • Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient
    • Time Frame: : Immediately after inclusion and prior to Johns Hopkins ACE conduct
    • Clinical determination of decision-making capacity of the patient blindly of Johns Hopkins ACE results
  • ACE sub-items
    • Time Frame: Immediately after inclusion
    • Decision-making capacity sub-items as determined by ACE (orientation, language, registration, attention and calculation, and recall)
  • ICU length of stay
    • Time Frame: ICU discharge – Up to day 100
    • ICU length of stay
  • Hospital length of stay
    • Time Frame: Hospital discharge – Up to day 200
    • Hospital length of stay
  • Ventilatory free days
    • Time Frame: Hospital discharge – Up to day 200
    • Ventilatory free days
  • Sedatives used within 72 hours before decision-making capacity evaluation
    • Time Frame: Within 72 hours before inclusion
    • Sedatives administered to the patient within 72 hours before Johns Hopkins ACE will be collected (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
  • Analgesics used within 72 hours before decision-making capacity evaluation
    • Time Frame: Within 72 hours before inclusion
    • Analgesics administered to the patient within 72 hours before Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl)
  • Other molecules used within 72 hours before decision-making capacity evaluation
    • Time Frame: Within 72 hours before inclusion
    • Other molecules administered to the patient within 72 hours before Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others)
  • Sedatives used during decision-making capacity evaluation
    • Time Frame: During inclusion
    • Sedatives administered to the patient during Johns Hopkins ACE will be (midazolam, propofol, dexmedetomidine, ketamine, halogenated volatile agents)
  • Analgesics used during decision-making capacity evaluation
    • Time Frame: During inclusion
    • Analgesics administered to the patient during Johns Hopkins ACE will be collected (morphine, remifentanil, sufentanyl, fentanyl
  • Other molecules used during decision-making capacity evaluation
    • Time Frame: During inclusion
    • Other molecules administered to the patient during Johns Hopkins ACE will be collected (neuroleptics, benzodiazepines, hydroxyzine, clonidine, others

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Godet, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Lise Laclautre, +33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.