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

Mechanical Ventilation Clinical Trial

— DexCap  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193540
• Other study ID #: DEXCAP
• Status: Recruiting
• Start date: July 15, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: December 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33 4 73 754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	ACE sub-items	Decision-making capacity sub-items as determined by ACE (orientation, language, registration, attention and calculation, and recall)	Immediately after inclusion
Secondary	ICU length of stay	ICU length of stay	ICU discharge - Up to day 100
Secondary	Hospital length of stay	Hospital length of stay	Hospital discharge - Up to day 200
Secondary	Ventilatory free days	Ventilatory free days	Hospital discharge - Up to day 200
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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