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

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

Study Overview

• Status: Unknown
• Conditions: Confusion; Mechanical Ventilation; Sedatives; Intensive Care Unit Patient; Decision-making Capacity
• Intervention / Treatment: Other: ACE questionnaire

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2018
• Primary Completion (ANTICIPATED): July 15, 2020
• Study Completion (ANTICIPATED): August 15, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Confusion; Sedatives; Intensive Care Unit patient; Decision-making capacity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Confusion
• Other Study ID Numbers: DEXCAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No