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

Study Overview
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Brief Summary
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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
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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:

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

Conditions
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Stress Disorders, Post-Traumatic, Depression

Intervention / Treatment
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* Other: Baseline activities
* Other: Clinical interview with a psychologist
* Other: Telephone interview 2 months after ICU discharge
* Other: Clinical interview with a psychologist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>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 . | Other: Baseline activities<br>* Initial consent procedures and baseline data collection.<br>Other: Clinical interview with a psychologist<br>* 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<br>Other: Telephone interview 2 months after ICU discharge<br>* 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<br>Other: Clinical interview with a psychologist<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of cognitive impairment | based on D2 test | 4 months after ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sedation |  | expected average of 48 hours | 
| Duration of ventilation |  | expected average of 36 hours | 
| Daily average for RASS scale |  | Expected maximum of 28 days | 
| Daily average for Behaviour pain scale |  | expected average of 48 hours | 
| CAM ICU score |  | upon awakening (expected average of 48 hours) | 
| Peritraumatic distress inventory |  | expected average of 5 days (end of ICU stay) | 
| Questionnaire PDEQ-10 |  | expected average of 5 days (end of ICU stay) | 
| Assessment of potential impacts |  | expected average of 5 days (end of ICU stay) | 
| HADS score |  | expected average of 5 days (end of ICU stay) | 
| ICUMT questionnaire |  | 60 +- 3 days after ICU discharge | 
| ICU-SEQ questionnaire |  | 60 +- 3 days after ICU discharge | 
| Assessment of psychotramatisme |  | 60 +- 3 days after ICU discharge | 
| HADS score |  | 60 +- 3 days after ICU discharge | 
| PCLS scale (DSM IV items) |  | 4 months after ICU discharge | 
| IDS-C Questionnaire |  | 4 months after ICU discharge | 
| SF-36 |  | 4 months after ICU discharge | 
| Forward span test |  | 4 months after ICU discharge | 
| Backwards span test |  | 4 months after ICU discharge | 
| Rey 15-word test |  | 4 months after ICU discharge | 
| Test D2 (units = n) |  | 4 months after ICU discharge | 
| Wisconsin test |  | 4 months after ICU discharge | 
| Stroop test |  | 4 months after ICU discharge | 
| Verbal fluency test |  | 4 months after ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive disorders, quality of life, Intensive care