French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Behavioral: Post-intensive Care unit syndrome
* Other: Spatiotemporal measurements of walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Covid19 infection<br>Patients with Covid19 infection | Behavioral: Post-intensive Care unit syndrome<br>* Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19<br>|
| Control group<br>Asymptomatic group | Other: Spatiotemporal measurements of walking<br>* Spatiotemporal measurements of walking in asymptomatic participants from the general population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on cognitive Impairment: Vigilance (RASS) | Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on cognitive Impairment: Cooperation | Yes/no - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on cognitive Impairment: Communication | Yes/no - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on cognitive Impairment: Agitation | Yes/no - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on cognitive Impairment: Delirium | Yes/no - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on cognitive Impairment : Introduction of neuroleptic | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on cognitive Impairment: temporo-spatial disorientation | Yes/no - Patients group | Between 10 days and 1 month after ICU's discharge | 
| Change on physical Impairment : dyspnea | Yes/No - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment: Modified Borg scale dyspnea score. | Verbal and numerical scale that asks you to rate the difficulty of your breathing Patients are asked to tick the boxes that reflect their dyspnea perception best range 0-10 lesser is better - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : cough | Yes/No - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : respiratory rate | Number of breaths/per minute. - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : ventilation mode | Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest | measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : respiratory rate on activity | respiratory rate breathing rate on activity - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity | measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow during activity - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : orthostatic hypotension | Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position. - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : electrocardiogram at rest | electrocardiogram at rest - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical impairment : numeric verbal scales of fatigue | self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment: numeric verbal scales of pain | self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : stiffness or pain involving joints | Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles) Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : stability of the trunk in siting | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : autonomy for bed-chair transfers | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment autonomy for walking | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment : sores | Yes/no Localisation Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on Imagery cerebral | date and result if applicable - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment neurologic exam | motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score) | assess muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). MRC-SS score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic). Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on physical Impairment five times sit to stand test | The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times without use of arms, Equipment • Standard height chair (43-45 cm, 17-18 inches) with a backrest. If the patient cannot perform five stands to complete the test without use of arms, a score of 0 seconds should be documented. Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA) | Designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstruction skills, conceptual thinking, calculations, and orientation. Range 0 -30 higher is better Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Cognitive Impairment Frontal Assessment Battery (FAB) | Total score is from a maximum of 18, higher scores indicating better performance. Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : sadness | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : anxiety | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment: Insomnia | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Apathy | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : sideration | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Despair | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Culpability | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Conduit addictive | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : psychiatric or psychologic care | Yes/no - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| assess type of psychiatric treatment | Type - Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS) | A 14-item self-report screening scale that was originally developed to indicate the possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S) | 20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD. Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| assess psychological Impairment | Introduction of antidepressant drugs Type Patients group | Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| assess psychological Impairment | Introduction of neuroleptic Type Patients group | change between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asses demographics information | Age, sex, formal education, marital status, occupation, place of living, socio-professional category Patients group | Between 10 days and 1 month after ICU's discharge | 
| assess comorbidities | number of comorbidities Patients group | Between 10 days and 1 month after ICU's discharge | 
| assess past and current medications | Precise Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| assess related symptoms nature of COVID-19 | duration of COVID-19-related symptoms nature Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay and/or CT-scan showing typical radiological findings Patients group | Between 10 days and 1 month after ICU's discharge | 
| assess characteristics of ongoing hospitalization | number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments ) Patients group | Between 10 days and 1 month after ICU's discharge | 
| assess medical complications in intensive care | Pneumopathy pulmonary embolism others Patients group | Between 10 days and 1 month after ICU's discharge | 
| Descriptive data of the rehabilitation care pathway after stay in intensive care until return home | Number of days to discharge from hospital Service of rehabilitation care hospital at home (HAH) return at home Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Number of new medical qualifying events since last contact | complications Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Social status | professional activity unemployment retirement others Patients group | Between 10 days and 1 month and 3 months and 6 months after ICU's discharge | 
| Activities of Daily Living (ADL) scale | Related to personal care (self-performance) looks at four of these tasks: transfer, bed mobility, toileting and eating. The resident's self- performance and the amount of staff support provided are evaluated for all of these tasks ranges from 0 (independent) to 4 (total dependence) Patients group | 3 months and 6 months after ICU's discharge | 
| Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire | Self-reported outcome measure assessing the impact of health on an individual's everyday life Patients fill out a 12-question survey which is then scored by a clinician or researcher. Questionnaire consisting of 12 questions that measure 8 health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Patients group | 3 months and 6 months after ICU's discharge | 
| Gait analysis 6-minute walk test (6MWT) | Sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Patients group | 3 months and 6 months after ICU's discharge | 
| Balance and Gait analysis | Inertial Sensors to Assess Gait Quality Patients group | 3 months and 6 months after ICU's discharge | 
| Spatio-temporal parameters of walking | Comparison of spatio-temporal measures of walking in patients with severe Covid 19 infection to those of an age- and sex-matched sample of asymptomatic participants. Both groups | Inclusion |