Clinical trial NCT04590170: French Cohort of COVID-19 Patients With Post-intensive Care Syndrome
Official title: French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return - Spatio-temporal Analysis of Walking Compared to Asymptomatic Participants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in cochin or Corentin-celton hospitals after an intensive care unit stay for a COVID19 infection

Brief summary: The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

Detailed description: The novel coronavirus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 emerged in December 2019 and was declared pandemic in March 2020.

Although the majority of reported COVID-19 cases are mild, approximatively 5% of patients require a stay in intensive care unit, with mechanical ventilation.

Post intensive care syndrome (PICS) consists of physical, cognitive and psychological dysfunctions.

Little is known about the rate and clinical presentations of PCIS among patients surviving to COVID-19.

The objective of this study is to describe the clinical manifestations of PCIS in COVID-19 patients, and their rehabilitation process until home return.

Eligibility criteria: Inclusion Criteria - patients with covid19 infection :

* COVID 19 infection (PCR or CT-scan)
* ICU stay requiring mechanical ventilation
* Age ≥18 years old

Inclusion Criteria - control group :

* Age ≥ 18 years old
* Able to walk without technical assistance,
* Having no orthopedic or neurological disorder likely to disturb balance and walking
* Have not had a severe form of Covid 19 disease in the last 12 months
* Collection of non-opposition

Exclusion Criteria:

- Inability to give consent

Primary outcomes:
measure: Change on cognitive Impairment: Vigilance (RASS)
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on cognitive Impairment: Cooperation
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on cognitive Impairment: Communication
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on cognitive Impairment: Agitation
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on cognitive Impairment: Delirium
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on cognitive Impairment : Introduction of neuroleptic
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on cognitive Impairment: temporo-spatial disorientation
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Change on physical Impairment : dyspnea
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment: Modified Borg scale dyspnea score.
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : cough
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : respiratory rate
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : ventilation mode
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : respiratory rate on activity
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : orthostatic hypotension
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : electrocardiogram at rest
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical impairment : numeric verbal scales of fatigue
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment: numeric verbal scales of pain
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : stiffness or pain involving joints
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : stability of the trunk in siting
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : autonomy for bed-chair transfers
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment autonomy for walking
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment : sores
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on Imagery cerebral
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment neurologic exam
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score)
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on physical Impairment five times sit to stand test
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA)
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Cognitive Impairment Frontal Assessment Battery (FAB)
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : sadness
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : anxiety
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment: Insomnia
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Apathy
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : sideration
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Despair
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Culpability
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Conduit addictive
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : psychiatric or psychologic care
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: assess type of psychiatric treatment
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS)
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S)
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: assess psychological Impairment
timeFrame: Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: assess psychological Impairment
timeFrame: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary outcomes:
measure: asses demographics information
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: assess comorbidities
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: assess past and current medications
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: assess related symptoms nature of COVID-19
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: assess characteristics of ongoing hospitalization
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: assess medical complications in intensive care
timeFrame: Between 10 days and 1 month after ICU's discharge
measure: Descriptive data of the rehabilitation care pathway after stay in intensive care until return home
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Number of new medical qualifying events since last contact
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Social status
timeFrame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
measure: Activities of Daily Living (ADL) scale
timeFrame: 3 months and 6 months after ICU's discharge
measure: Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire
timeFrame: 3 months and 6 months after ICU's discharge
measure: Gait analysis 6-minute walk test (6MWT)
timeFrame: 3 months and 6 months after ICU's discharge
measure: Balance and Gait analysis
timeFrame: 3 months and 6 months after ICU's discharge
measure: Spatio-temporal parameters of walking
timeFrame: Inclusion
Other outcomes:
Locations:
city: Issy-les-Moulineaux
country: France
facility: Department of Physical Medicine and Rehabilitation
city: Paris
country: France
facility: Department of Rehabilitation, Institute of Rheumatology Cochin
Study officials:
affiliation: Study Principal Investigator
name: Camille DASTE, MD
role: PRINCIPAL_INVESTIGATOR
References: