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

Assistance Publique - Hôpitaux de Paris85 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Covid19

Interventions

Post-intensive Care unit syndromeBEHAVIORAL

Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19

Spatiotemporal measurements of walkingOTHER

Spatiotemporal measurements of walking in asymptomatic participants from the general population.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Department of Rehabilitation, Institute of Rheumatology Cochin

Paris, Paris, France

Department of Physical Medicine and Rehabilitation

Issy-les-Moulineaux, France

Outcomes

Primary Outcomes

Change on cognitive Impairment: Vigilance (RASS)

Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

Change on cognitive Impairment: Cooperation

Yes/no - Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

Change on cognitive Impairment: Communication

Yes/no - Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

Change on cognitive Impairment: Agitation

Yes/no - Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

Change on cognitive Impairment: Delirium

Yes/no - Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

Change on cognitive Impairment : Introduction of neuroleptic

Yes/no - Patients group

Time frame: 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

Time frame: Between 10 days and 1 month after ICU's discharge

Change on physical Impairment : dyspnea

Yes/No - Patients group

Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

Data from ClinicalTrials.gov

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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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

assess type of psychiatric treatment

Type - Patients group

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge

Secondary Outcomes

asses demographics information

Age, sex, formal education, marital status, occupation, place of living, socio-professional category * Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

assess comorbidities

number of comorbidities * Patients group

Time frame: Between 10 days and 1 month after ICU's discharge

assess past and current medications

Precise * Patients group

Time frame: 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

Time frame: 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

Time frame: Between 10 days and 1 month after ICU's discharge

assess medical complications in intensive care

Pneumopathy pulmonary embolism others * Patients group

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months and 6 months after ICU's discharge

Balance and Gait analysis

Inertial Sensors to Assess Gait Quality * Patients group

Time frame: 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

Time frame: Inclusion