Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU

NCT06308835 | Not Yet Recruiting

• 1 other identifier: APHP231652
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (4)

• Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom

  defined by the presence of an MRC (Medical Research Council) score \<48/60 (higher score mean better outcome)

  3 months

• Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom

  defined by a MOCA (Montreal Cognitive Assessment) \<26/30 (higher score mean better outcome)

  3 months

• Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom

  defined by a Hospital Anxiety and Depression Scale (HADS) score A or D \> 8 (ranging frome 0 to 21, lower score mean better outcome)

  3 months

• Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom.

  defined by an Impact of Events Scale (IESR) \> 22 (ranging from 0 to 88, lower score mean better outcome)

  3 months

Interventions

questionnaires OTHER

BREF(Batterie d'efficience Frontale), SDMT (Symbol Digit Modalities Test), TMT (Trail making test), Empans verbaux et BNT (Boston naming Test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized in a medical intensive care unit with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in an intensive care unit,

You may qualify if:

• \. Patient with \> 24h stay in intensive care unit
• Patients with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in intensive care.
• \. Patients who have received organ replacement or invasive therapy in the ICU (invasive or non-invasive ventilation, extra-renal purification, plasmapheresis, ventricular bypass, catecholamines).
• \. Non-opposition of the patient or of the trusted support person, or of a family member or close friend if the patient is unable to express non-opposition.

You may not qualify if:

• \. Minors, protected adults and pregnant women
• \. Advanced neurodegenerative disease pre-existing prior to ICU admission
• \. Severe psychotic disorders pre-existing before admission to intensive care
• \. Patients whose neurological and psychiatric history is unknown prior to resuscitation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

GH Pitié Salpêtrière

Paris, 75013, France

Location

CH Saint Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

postintensive care syndrome

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Clémence Marois, MD, MSc

  Assisitance Publique des Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marois Clémence, MD, MSc

CONTACT

0142161858; clemence.marois@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 13, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)