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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Change on cognitive Impairment: Delirium
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •\- Inability to give consent
Outcomes
Primary Outcomes
Change on cognitive Impairment: Delirium
Time Frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Cooperation
Time Frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Agitation
Time Frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Vigilance (RASS)
Time Frame: Between 10 days and 1 month after ICU's discharge
Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group
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
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
Change on physical Impairment autonomy for walking
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Communication
Time Frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on physical Impairment : dyspnea
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/No - Patients group
Change on physical Impairment : respiratory rate
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Number of breaths/per minute. - Patients group
Change on physical Impairment : respiratory rate on activity
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
respiratory rate breathing rate on activity - Patients group
Change on physical Impairment : sores
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no Localisation * Patients group
Change on psychological Impairment: Insomnia
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : Apathy
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : sideration
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: temporo-spatial disorientation
Time Frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on physical Impairment : cough
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/No - Patients group
Change on physical Impairment : ventilation mode
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group
Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Change on physical Impairment : stability of the trunk in siting
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on Imagery cerebral
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
date and result if applicable - Patients group
Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score)
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Change on physical Impairment five times sit to stand test
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA)
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Change on cognitive Impairment : Introduction of neuroleptic
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on physical Impairment : electrocardiogram at rest
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
electrocardiogram at rest - Patients group
Change on physical Impairment: numeric verbal scales of pain
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better
Change on physical Impairment : stiffness or pain involving joints
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles) * Patients group
Cognitive Impairment Frontal Assessment Battery (FAB)
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Total score is from a maximum of 18, higher scores indicating better performance. * Patients group
Change on psychological Impairment : anxiety
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on physical Impairment: Modified Borg scale dyspnea score.
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Change on physical Impairment : orthostatic hypotension
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position. - Patients group
Change on psychological Impairment : sadness
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
assess type of psychiatric treatment
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Type - Patients group
Change on physical impairment : numeric verbal scales of fatigue
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better
Change on physical Impairment : autonomy for bed-chair transfers
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on physical Impairment neurologic exam
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no * Patients group
Change on psychological Impairment : Despair
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : Culpability
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : psychiatric or psychologic care
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S)
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD. * Patients group
assess psychological Impairment
Time Frame: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Introduction of neuroleptic Type * Patients group
Change on psychological Impairment : Conduit addictive
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS)
Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Secondary Outcomes
- Descriptive data of the rehabilitation care pathway after stay in intensive care until return home(Between 10 days and 1 month and 3 months and 6 months after ICU's discharge)
- assess related symptoms nature of COVID-19(Between 10 days and 1 month after ICU's discharge)
- assess medical complications in intensive care(Between 10 days and 1 month after ICU's discharge)
- Social status(Between 10 days and 1 month and 3 months and 6 months after ICU's discharge)
- Gait analysis 6-minute walk test (6MWT)(3 months and 6 months after ICU's discharge)
- asses demographics information(Between 10 days and 1 month after ICU's discharge)
- assess past and current medications(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(Between 10 days and 1 month and 3 months and 6 months after ICU's discharge)
- Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire(3 months and 6 months after ICU's discharge)
- Balance and Gait analysis(3 months and 6 months after ICU's discharge)
- assess comorbidities(Between 10 days and 1 month after ICU's discharge)
- Activities of Daily Living (ADL) scale(3 months and 6 months after ICU's discharge)
- assess characteristics of ongoing hospitalization(Between 10 days and 1 month after ICU's discharge)
- Spatio-temporal parameters of walking(Inclusion)