NeuroPsy RéaNeuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
Baseline activities
+ Clinical interview with a psychologist
+ Telephone interview 2 months after ICU discharge
Trastornos Relacionados con el Estrés y el Trauma+1
+ Trastornos Mentales
+ Trastornos Cognitivos
Otro tipo de estudio
Resumen
Fecha de inicio: 1 de noviembre de 2013
Fecha en la que se inscribió al primer participante.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:
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 125 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, FranceAbrir CHU de Nîmes - Hôpital Universitaire Carémeau en Google Maps