French Cohort of COVID-19 Patients With Post-intensive Care Syndrome
- Conditions
- Covid19
- Interventions
- Behavioral: Post-intensive Care unit syndromeOther: Spatiotemporal measurements of walking
- Registration Number
- NCT04590170
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
- Inability to give consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Covid19 infection Post-intensive Care unit syndrome Patients with Covid19 infection Control group Spatiotemporal measurements of walking Asymptomatic group
- Primary Outcome Measures
Name Time Method Change on physical Impairment : cough Between 10 days and 1 month and 3 months and 6 months after ICU's discharge Yes/No - Patients group
Change on cognitive Impairment: Delirium Between 10 days and 1 month after ICU's discharge Yes/no - Patients group
Change on cognitive Impairment: Cooperation Between 10 days and 1 month after ICU's discharge Yes/no - Patients group
Change on physical Impairment : dyspnea 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 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 cognitive Impairment: Vigilance (RASS) 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 cognitive Impairment: Agitation Between 10 days and 1 month after ICU's discharge Yes/no - Patients group
Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity 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 cognitive Impairment: Communication Between 10 days and 1 month after ICU's discharge Yes/no - Patients group
Change on physical Impairment : respiratory rate on activity 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 autonomy for walking Between 10 days and 1 month and 3 months and 6 months after ICU's discharge Yes/no - Patients group
Change on physical Impairment : sores Between 10 days and 1 month and 3 months and 6 months after ICU's discharge Yes/no Localisation
* Patients groupChange on psychological Impairment: Insomnia 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 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 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 Between 10 days and 1 month after ICU's discharge Yes/no - Patients group
Change on physical Impairment : ventilation mode 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 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 Between 10 days and 1 month and 3 months and 6 months after ICU's discharge Yes/no - Patients group
Change on Imagery cerebral 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) 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 groupChange on physical Impairment five times sit to stand test 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 groupChange on cognitive Impairment The Montreal Cognitive Assessment (MoCA) 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 groupChange on cognitive Impairment : Introduction of neuroleptic 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 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 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 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 groupCognitive Impairment Frontal Assessment Battery (FAB) 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 groupChange on psychological Impairment : anxiety 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. 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 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 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 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 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 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 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 groupChange on psychological Impairment : Despair 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 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 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) 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 groupassess psychological Impairment change between 10 days and 1 month and 3 months and 6 months after ICU's discharge Introduction of neuroleptic Type
* Patients groupChange on psychological Impairment : Conduit addictive 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) 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 Outcome Measures
Name Time Method 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 Number of days to discharge from hospital Service of rehabilitation care hospital at home (HAH) return at home
* Patients groupassess related symptoms nature of COVID-19 Between 10 days and 1 month after ICU's discharge 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 groupassess medical complications in intensive care Between 10 days and 1 month after ICU's discharge Pneumopathy pulmonary embolism others
* Patients groupSocial status Between 10 days and 1 month and 3 months and 6 months after ICU's discharge professional activity unemployment retirement others
* Patients groupGait analysis 6-minute walk test (6MWT) 3 months and 6 months after ICU's discharge 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 groupasses demographics information Between 10 days and 1 month after ICU's discharge Age, sex, formal education, marital status, occupation, place of living, socio-professional category
* Patients groupassess past and current medications Between 10 days and 1 month and 3 months and 6 months after ICU's discharge Precise
* Patients groupNumber of new medical qualifying events since last contact Between 10 days and 1 month and 3 months and 6 months after ICU's discharge complications
* Patients groupQuality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire 3 months and 6 months after ICU's discharge 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 groupBalance and Gait analysis 3 months and 6 months after ICU's discharge Inertial Sensors to Assess Gait Quality
* Patients groupassess comorbidities Between 10 days and 1 month after ICU's discharge number of comorbidities
* Patients groupActivities of Daily Living (ADL) scale 3 months and 6 months after ICU's discharge 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 groupassess characteristics of ongoing hospitalization Between 10 days and 1 month after ICU's discharge number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments )
* Patients groupSpatio-temporal parameters of walking Inclusion 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
Trial Locations
- Locations (2)
Department of Physical Medicine and Rehabilitation
🇫🇷Issy-les-Moulineaux, France
Department of Rehabilitation, Institute of Rheumatology Cochin
🇫🇷Paris, France