Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients (NeuroPsy Réa)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Stress Disorders, Post-Traumatic; Depression

Treatments: Other: Telephone interview 2 months after ICU discharge; Other: Baseline activities; Other: Clinical interview with a psychologist

Study type: Interventional

Funder types: Other

Identifiers

NCT01838798

LOCAL/2012/CR-02

2013-A00022-43 (Other Identifier)

Details and patient eligibility

About

This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.

The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.

Full description

The secondary objectives of this study are:

A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.

B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?

C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?

D. To study potential risk factors for cognitive problems at 4 months after ICU discharge.

E. If objective C determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization?

F. To study potential risk factors for poor quality of life at 4 months:

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient (or his/her "trusted person") must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
• Patient admitted to the ICU and intubated and ventilated for at least 48 hours

Exclusion criteria

• The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient has a contra-indication for a treatment used in this study
• Patient admitted to intensive care with sedation started for more than 24 hours
• Patient with neurological or psychiatric (cognitive) disorders
• Patient admitted for cardiac arrest
• Patient admitted for stroke
• Patient admitted for cervical trauma > C6
• Patient presenting with tracheotomy accompanied by long-term mechanical ventilation
• Moribund patient or with little hope of survival beyond 48 hours
• Patients for whom a limitation or termination of care is considered
• McCabe Score = 0
• Knauss Scale = C or D

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Study population

Experimental group

Description:

See in inclusion/exclusion criteria. Interventions: Baseline activities; Clinical interview with a psychologist; Telephone interview 2 months after ICU discharge; Clinical interview with a psychologist .

Treatment:

Other: Clinical interview with a psychologist

Other: Clinical interview with a psychologist

Other: Baseline activities

Other: Telephone interview 2 months after ICU discharge