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Clinical Trial Summary

Further knowledge regarding sequelae in severe COVID-19 patients who have required ICU admission for invasive mechanical ventilation is still needed. Available evidence suggests ongoing respiratory impairment and impact in quality of life.


Clinical Trial Description

PURPOSE: To evaluate post-ICU clinical outcomes in severe COVID-19 ICU survivors. DESIGN: A prospective observational study conducted in public hospital in Madrid, Spain. METHODS: Participants: patients diagnosed with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation and have been discharged from hospital. Intervention: Patients will be invited to attend follow-up visits at the hospital for assessments 3 months and 6 months after ICU discharge. Outcome measures: Tests of respiratory muscles function will include ultrasonography of the diaphragm muscle to measure diaphragm thickness (DT), diaphragm thickening ratio (TR) and diaphragm excursion (DE); respiratory muscle strength measurement to obtain Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP) and Maximal Sniff Nasal Inspiratory Pressure (SNIP); functional exercise capacity will be assessed with the Six Minutes Walk Test (6MWT); dyspnea and health-related quality of life will be evaluated with the Modified Medical Research Council Scale (mMRC Scale) and the Saint George's Respiratory Questionnaire (SGRQ). Data on participants' demographics and clinical data will also be collected. Statistical Analysis: Descriptive statistics will be used to summarise data. Spearman's correlation coefficients will be used to explore associations between variables. CONCLUSIONS AND SIGNIFICANCE OF THE RESEARCH: Understanding post-ICU clinical outcomes in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04853940
Study type Observational
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact Maria-Natividad Seisdedos-Nuñez, PT,MSc
Phone 0034913368000
Email [email protected]
Status Recruiting
Phase
Start date January 1, 2021
Completion date March 31, 2022

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