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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change on cognitive Impairment: Delirium
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •- Inability to give consent
结局指标
主要结局
Change on cognitive Impairment: Delirium
时间窗: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Cooperation
时间窗: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Agitation
时间窗: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Vigilance (RASS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on physical Impairment : dyspnea
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on physical Impairment : cough
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Yes/no - Patients group
Change on Imagery cerebral
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
- 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)