- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Madrid, Spagna, 28034
- Medical ICU. Hospital Universitario Ramón y Cajal
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Madrid, Spagna, 28034
- Surgical ICU. Hospital Universitario Ramón y Cajal
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Medical Research Council sum score (MRC- SS).
Lasso di tempo: < 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).
Lasso di tempo: < 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)
Lasso di tempo: < 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Age
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: <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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 165/20
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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