- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04400461
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
DESIGN: An observation cohort study conducted in a tertiary hospital.
METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.
Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.
SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28034
- Medical ICU. Hospital Universitario Ramón y Cajal
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Madrid, España, 28034
- Surgical ICU. Hospital Universitario Ramón y Cajal
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;
- have received invasive ventilation > 24 hours;
- have been successfully weaned from mechanical ventilation > 48 hours;
- were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise.
Exclusion Criteria:
- subjects or proxies with inability to communicate in Spanish fluently;
- cognitive impairment prior to ICU admission;
- proven neurological impairment or neuromuscular disorder;
- Cerebrovascular Accident during hospital stay;
- previous organ transplant;
- pregnancy;
- unstable fractures or any other injuries that would require medical bed rest.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Medical Research Council sum score (MRC- SS).
Periodo de tiempo: < 48 hours before ICU discharge
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Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
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< 48 hours before ICU discharge
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Medical Research Council sum score (MRC- SS).
Periodo de tiempo: < 24 hours before hospital discharge
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Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
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< 24 hours before hospital discharge
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The Functional Status Score for the ICU (FSS-ICU)
Periodo de tiempo: < 24 hours before hospital discharge
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The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks.
Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.
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< 24 hours before hospital discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Age
Periodo de tiempo: Through study completion, up to 6 months
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Age in years
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Through study completion, up to 6 months
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Sex
Periodo de tiempo: Throughout study completion , up to 6 month
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Male vs Female
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Throughout study completion , up to 6 month
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Body Mass Index
Periodo de tiempo: Throughout study completion, up to 6 months
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kg/m2
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Throughout study completion, up to 6 months
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Baseline mobility
Periodo de tiempo: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
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Baseline mobility
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First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
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APACHE II score
Periodo de tiempo: <24 hours after ICU admission
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Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points.
Higher scores correspond to more severe disease and a higher risk of death.
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<24 hours after ICU admission
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Length of stay in ICU
Periodo de tiempo: Throughout the study completion, up to 6 months
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Number of days of stay in ICU
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Throughout the study completion, up to 6 months
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Number of days on mechanical ventilation
Periodo de tiempo: Throughout the study completion, up to 6 months
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Number of days on mechanical ventilation
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Throughout the study completion, up to 6 months
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Polyneuropathy diagnosis
Periodo de tiempo: Throughout the study completion, up to 6 months
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Clinical or EMG polyneuropathy diagnosis confirmation
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Throughout the study completion, up to 6 months
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Number of days on Neuromuscular Blockers
Periodo de tiempo: Throughout the study completion, up to 6 months
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Number of days on NMB during mechanical ventilation
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Throughout the study completion, up to 6 months
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Episodes of prone positioning
Periodo de tiempo: Throughout the study completion, up to 6 months
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Number of prone positioning episodes during ICU stay
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Throughout the study completion, up to 6 months
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Length of stay in hospital
Periodo de tiempo: Throughout the study completion, up to 6 months
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Total number of days admitted to hospital
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Throughout the study completion, up to 6 months
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Continuation of care
Periodo de tiempo: Throughout the study completion, up to 6 months
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Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.
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Throughout the study completion, up to 6 months
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 165/20
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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