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

NCT04193540 | Unknown

• 1 other identifier: DEXCAP
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Intensive Care Unit patient; Mechanical Ventilation; Sedatives; Decision-making capacity; Confusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Decision-making capacity clinically evaluated by physician, resident and nurse in charge of the patient

  : Immediately after inclusion and prior to Johns Hopkins ACE conduct

• ACE sub-items

  Immediately after inclusion

• ICU length of stay

  ICU discharge - Up to day 100

• Hospital length of stay

  Hospital discharge - Up to day 200

• Ventilatory free days

  Hospital discharge - Up to day 200

Study Arms (1)

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

Interventions

ACE questionnaire OTHER

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.

ACE questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Godet

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: July 15, 2018
• Primary Completion: July 15, 2020
• Study Completion: August 15, 2020
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)