Rehabilitation After Admission in Intensive Care Unit for COVID-19
- Conditions
- Covid19
- Registration Number
- NCT04523051
- Lead Sponsor
- Centre Hospitalier Régional Metz-Thionville
- Brief Summary
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home.
Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation.
In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU.
The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- Post-COVID patient hospitalized in rehabilitation center
- Admission in Intensive Care Unit with proven COVID-19 disease before
- Patients not willing to participate via using their medical files
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Independence measure (FIM) at the admission Day 1 The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Functional Independence measure (FIM) 1-month hospitalization Day 30 The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Functional Independence measure (FIM) at the discharge Day 180 The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
- Secondary Outcome Measures
Name Time Method Sex Day 1 gender of participants
Oxygen saturation of the blood at the admission Day 1 The measuring of oxygen saturation of the blood by means of an oximeter at the admission
Estimated functional independence measure score before Covid-19 Day 1 The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence). Estimating the functional independence score before the disease.
Length of stay in acute care Day 1 Length of stay in acute care for Covid-19
Length of stay in rehabilitation centers Day 180 Length of stay in rehabilitation centers
weight at the discharge Day 180 weight of the patient after hospitalization
Dyspnea symptoms at the admission Day 1 Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
weight at admission Day 1 weight of the patient
Length of stay in ICU unit Day 1 Length of stay in ICU unit for Covid-19
Joint limitation Day 1 Presence of joint limitation during the management
Functional exercise capacity Day 1 Functional exercise capacity measured by a 6 minutes Walking test
Neurological examination at the discharge Day 180 presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the discharge
age Day 1 age of the patient at the admission in rehabilitation center
Presence of pressure ulcers Day 180 Presence of pressure ulcers, stage and localization during the management of patient
Risk of bedsore Day 1 Risk of bedsore with the Braden scale. The Braden score consists of six subscales (sensory perception, moisture, activity, mobility, nutrition and friction/shear) representing the most commonly occuring risk factors for pressure ulcers and is scored from 6 to 23, with lower scores representing higher risk of developing pressure ulcers.
Dominant side Day 1 Dominant side of the patient
Presence of psychic disorders Day 180 Presence of psychic disorders like delirium, sleep disorders, anxiety, sadness of mood, loss of appetite, suicidal thoughts, asking for psychologist care during the stay
Estimated dyspnea symptoms before Covid-19 Day 1 The modified Medical Research Council (mMRC) scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing).
Length of Invasive mechanical ventilation Day 1 Length of Invasive mechanical ventilation during the stay
Muscle strength at the admission Day 1 Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Muscle strength at the discharge Day 180 Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Dyspnea symptoms at the discharge Day 180 Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
Destination of patients at discharge Day 180 Destination of patients at discharge from rehabilitation center. For the destination there is 4 possibility: the return home, institutionalization, re-hospitalization or other (specify where).
Oxygen saturation of the blood at the discharge Day 180 The measuring of oxygen saturation of the blood by means of an oximeter at the discharge
Presence of Hoffman signs Day 180 Hoffman's sign is a test to examine the reflexes of the upper extremities.
Presence of Babinski signs Day 180 The Babinski reflex is obtained by stimulating the external portion of the sole.
Neurological examination at the admission Day 1 presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the admission
Trial Locations
- Locations (3)
Etablissement de santé Filieris
🇫🇷Freyming-Merlebach, Moselle, France
Hopital Legouest
🇫🇷Metz, Moselle, France
CHR Metz Thionville
🇫🇷Metz, Moselle, France