Clinical trial NCT01838798: Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
Official title: Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Depression
Keywords: cognitive disorders
quality of life
Intensive care
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients hospitalized in the ICU, intubated and ventilated for at least 48 hours.

Brief summary: 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.

Detailed 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:

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of cognitive impairment
timeFrame: 4 months after ICU discharge
Secondary outcomes:
measure: Duration of sedation
timeFrame: expected average of 48 hours
measure: Duration of ventilation
timeFrame: expected average of 36 hours
measure: Daily average for RASS scale
timeFrame: Expected maximum of 28 days
measure: Daily average for Behaviour pain scale
timeFrame: expected average of 48 hours
measure: CAM ICU score
timeFrame: upon awakening (expected average of 48 hours)
measure: Peritraumatic distress inventory
timeFrame: expected average of 5 days (end of ICU stay)
measure: Questionnaire PDEQ-10
timeFrame: expected average of 5 days (end of ICU stay)
measure: Assessment of potential impacts
timeFrame: expected average of 5 days (end of ICU stay)
measure: HADS score
timeFrame: expected average of 5 days (end of ICU stay)
measure: ICUMT questionnaire
timeFrame: 60 +- 3 days after ICU discharge
measure: ICU-SEQ questionnaire
timeFrame: 60 +- 3 days after ICU discharge
measure: Assessment of psychotramatisme
timeFrame: 60 +- 3 days after ICU discharge
measure: HADS score
timeFrame: 60 +- 3 days after ICU discharge
measure: PCLS scale (DSM IV items)
timeFrame: 4 months after ICU discharge
measure: IDS-C Questionnaire
timeFrame: 4 months after ICU discharge
measure: SF-36
timeFrame: 4 months after ICU discharge
measure: Forward span test
timeFrame: 4 months after ICU discharge
measure: Backwards span test
timeFrame: 4 months after ICU discharge
measure: Rey 15-word test
timeFrame: 4 months after ICU discharge
measure: Test D2 (units = n)
timeFrame: 4 months after ICU discharge
measure: Wisconsin test
timeFrame: 4 months after ICU discharge
measure: Stroop test
timeFrame: 4 months after ICU discharge
measure: Verbal fluency test
timeFrame: 4 months after ICU discharge
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Justine Pereira
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire Roger, MD
role: PRINCIPAL_INVESTIGATOR
References: