Status:
COMPLETED
Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Stress Disorders, Post-Traumatic
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01838798
Start Date
November 1 2013
End Date
October 1 2016
Last Update
December 19 2025
Active Locations (1)
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1
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029