Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

Centre Hospitalier Universitaire de Nīmes125 enrolled

Overview

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.

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:

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

125

Conditions

Stress Disorders, Post-Traumatic

Interventions

Baseline activitiesOTHER

Initial consent procedures and baseline data collection.

Clinical interview with a psychologistOTHER

Clinical interview with a psychologist. This interview with a psychologist will take place after patient consent procedures, and at least 2 days after discontinuation of sedation, and before leaving the ICU. This interview will include: * An inventory of peritraumatic distress symptoms * A questionnaire on peritraumatic dissociative experiences * An assessment of related, potential impacts * The HADS questionnaire

Telephone interview 2 months after ICU dischargeOTHER

At 2 months after leaving the ICU, a psychologist will contact the patient with questions regarding his/her representation of hospitalization. This implies the following: * Questionnaires assessing memories and stressors (Questionnaires ICUMT, and ICU-SEQ * An assessment of psychological trauma * An assessment of potential impacts

Clinical interview with a psychologistOTHER

At 4 months after ICU discharge, the patient has a clinical interview during which a psychologist will: * assess cognitive functions * evaluate clinical symptoms of depression * assess quality of life * assess symptoms of post traumatic stress

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Presence/absence of cognitive impairment

based on D2 test

Time frame: 4 months after ICU discharge

Secondary Outcomes

Duration of sedation

Time frame: expected average of 48 hours

Duration of ventilation

Time frame: expected average of 36 hours

Daily average for RASS scale

Time frame: Expected maximum of 28 days

Daily average for Behaviour pain scale

Time frame: expected average of 48 hours

CAM ICU score

Time frame: upon awakening (expected average of 48 hours)

Peritraumatic distress inventory

Time frame: expected average of 5 days (end of ICU stay)

Questionnaire PDEQ-10

Time frame: expected average of 5 days (end of ICU stay)

Assessment of potential impacts

Time frame: expected average of 5 days (end of ICU stay)

HADS score

Time frame: expected average of 5 days (end of ICU stay)

ICUMT questionnaire

Time frame: 60 +- 3 days after ICU discharge

ICU-SEQ questionnaire

Time frame: 60 +- 3 days after ICU discharge

Assessment of psychotramatisme

Time frame: 60 +- 3 days after ICU discharge

HADS score

Time frame: 60 +- 3 days after ICU discharge

PCLS scale (DSM IV items)

Time frame: 4 months after ICU discharge

IDS-C Questionnaire

Time frame: 4 months after ICU discharge

SF-36

Time frame: 4 months after ICU discharge

Forward span test

Time frame: 4 months after ICU discharge

Backwards span test

Time frame: 4 months after ICU discharge

Rey 15-word test

Time frame: 4 months after ICU discharge

Test D2 (units = n)

Time frame: 4 months after ICU discharge

Wisconsin test

Time frame: 4 months after ICU discharge

Stroop test

Time frame: 4 months after ICU discharge

Verbal fluency test

Time frame: 4 months after ICU discharge

Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes