Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 4:28 PM
Study NCT ID:
NCT06308835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Prevalence and Risk Factors of Post Intensive Care Syndrome at 3 Months of an Intensive Care Unit Stay for a Neurological Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRESSréa
Brief Summary:
Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
Detailed Description:
"Post-intensive care syndrome (PICS) is defined as a new or worsening impairment in physical, cognitive or mental health status arising and persisting after a stay in intensive care unit (ICU) . The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. PICS is very common, and more than half of ICU adult patients experience such impairments.
Recent French guidelines about PICS have been published and implemented to raise awareness among clinicians and patients about diagnosis and management of PICS .
A systematic ICU follow-up consultation by trained practitioners allows the diagnosis of PICS, and the implementation of appropriate curative measures to minimize sequelae and improve outcomes . This consultation is increasingly recommended by learned societies.
Incidence and risk factors of PICS is poorly known in patients with neurological diseases, because they are frequently excluded from PICS studies due to difficulties to assess whether the symptoms are disease-related or directly associated with the experience of a critical illness. A better knowledge of follow up of these patients is necessary to identify if some neurocognitive sequelae may be preventable or treatable.
The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
The investigators wish to conduct a bi-centric prospective study, in two neurological ICU in Paris (AP-HP Sorbonne université - Pitié Salpetrière hospital and Paris Cité -Saint Anne Hospital). The study will last one year.
It will included adults patients hospitalized \>24h in neuro-ICU for a neurological disease affecting the central nervous system (status epilepticus, encephalitis, subarachnoid haemorrhage…) or the peripheral nervous system (myasthenia gravis crisis, Guillain-Barre syndrome…) ; and having received ICU lifesaving treatments (mechanical ventilation; sedation; plasmapheresis, renal replacement therapy, catecholamine).
Were excluded pregnant women, patients with pre-existing neurodegenerative disease or pre-existing severe psychiatric illness, and patients whose neurological or psychiatric history were not known prior to ICU. Patients with blindness, deafness, inability to speak French, active substance abuse, homelessness, or who lived \> 100 kilometers from the enrolling center.
Patients will be recruited at the end of the ICU stay, patient's non-opposition will be collected. If the patient is unable to consent, the non-opposition of the person of trust will be collected.
As close as possible to the ICU discharge, a neurological examination, a MRC score, a MOCA scale, and a HADS scale will be performed.
The ICU-follow up visit will be planned 3 months +- 30 days from the ICU discharge and will include:
* An interview conducted by a trained neuro-intensivist with assessment of neurological symptoms and autonomy assessed by the Glasgow Outcome Scale extended (GOS-e), and the modified Rankin Scale (mRS), of psychiatric symptoms with self-reported questionnaires: Hospital Anxiety and Depression Scale (HADS) and the impact of event scale (IES-R).
* A physical assessement by a physiotherapist including a Medical research coucil score (MRC)
* A neuropsychological assessement by a neuropsychologist including a Montreal Cognitive Assessment (MOCA), batterie d'efficience frontale (BREF), Symbol Digit Modalities Test (SDMT), Trail Making Test (TMT), Empans verbaux, Boston naming Test (BNT)
Recent French guidelines about PICS have been published and implemented to raise awareness among clinicians and patients about diagnosis and management of PICS .
A systematic ICU follow-up consultation by trained practitioners allows the diagnosis of PICS, and the implementation of appropriate curative measures to minimize sequelae and improve outcomes . This consultation is increasingly recommended by learned societies.
Incidence and risk factors of PICS is poorly known in patients with neurological diseases, because they are frequently excluded from PICS studies due to difficulties to assess whether the symptoms are disease-related or directly associated with the experience of a critical illness. A better knowledge of follow up of these patients is necessary to identify if some neurocognitive sequelae may be preventable or treatable.
The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
The investigators wish to conduct a bi-centric prospective study, in two neurological ICU in Paris (AP-HP Sorbonne université - Pitié Salpetrière hospital and Paris Cité -Saint Anne Hospital). The study will last one year.
It will included adults patients hospitalized \>24h in neuro-ICU for a neurological disease affecting the central nervous system (status epilepticus, encephalitis, subarachnoid haemorrhage…) or the peripheral nervous system (myasthenia gravis crisis, Guillain-Barre syndrome…) ; and having received ICU lifesaving treatments (mechanical ventilation; sedation; plasmapheresis, renal replacement therapy, catecholamine).
Were excluded pregnant women, patients with pre-existing neurodegenerative disease or pre-existing severe psychiatric illness, and patients whose neurological or psychiatric history were not known prior to ICU. Patients with blindness, deafness, inability to speak French, active substance abuse, homelessness, or who lived \> 100 kilometers from the enrolling center.
Patients will be recruited at the end of the ICU stay, patient's non-opposition will be collected. If the patient is unable to consent, the non-opposition of the person of trust will be collected.
As close as possible to the ICU discharge, a neurological examination, a MRC score, a MOCA scale, and a HADS scale will be performed.
The ICU-follow up visit will be planned 3 months +- 30 days from the ICU discharge and will include:
* An interview conducted by a trained neuro-intensivist with assessment of neurological symptoms and autonomy assessed by the Glasgow Outcome Scale extended (GOS-e), and the modified Rankin Scale (mRS), of psychiatric symptoms with self-reported questionnaires: Hospital Anxiety and Depression Scale (HADS) and the impact of event scale (IES-R).
* A physical assessement by a physiotherapist including a Medical research coucil score (MRC)
* A neuropsychological assessement by a neuropsychologist including a Montreal Cognitive Assessment (MOCA), batterie d'efficience frontale (BREF), Symbol Digit Modalities Test (SDMT), Trail Making Test (TMT), Empans verbaux, Boston naming Test (BNT)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: