Evaluation of Decision Capacity of ICU Patients Under Sedatives. A

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04193540
Study type	Observational
Source	University Hospital, Clermont-Ferrand
Contact	Lise Laclautre
Phone	+33 4 73 754963
Email	promo_interne_drci@chu-clermontferrand.fr
Status	Recruiting
Phase
Start date	July 15, 2018
Completion date	August 15, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms