ICU. Ramón y Cajal University Hospital
Madrid, 28034, Spain
NCT Number: NCT04853940
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.
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Notify Me18 year and older
All sexes
Observational
Madrid, 28034, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6-months follow-up with clinical testing at 3 and 6 months
Time frame: < 3 months after ICU discharge
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Time frame: within 6 months after ICU discharge
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Time frame: within 3 months after ICU discharge
B-mode Diaphragm ultrasound will be performed to measure diaphragm thickening ratio during deep breathing. Diaphragm Thickening Ratio = Diaphragm Thickness at Functional Residual Capacity/ Diaphragm thickness at Total Lung Capacity.
Time frame: within 6 months after ICU discharge
B-mode Diaphragm ultrasound will be performed to measure diaphragm thickening ratio during deep breathing. Diaphragm Thickening Ratio = Diaphragm Thickness at Functional Residual Capacity/ Diaphragm thickness at Total Lung Capacity.
Time frame: within 3 months after ICU discharge
B-mode Diaphragm ultrasound will be performed to measure diaphragm thickening ratio at Tidal Volume. Diaphragm Thickening Ratio = Diaphragm Thickness at the end of a quiet expiration/ Diaphragm thickness at the end of a quiet inspiration.
Time frame: within 6 months after ICU discharge
B-mode Diaphragm ultrasound will be performed to measure diaphragm thickening ratio at Tidal Volume. Diaphragm Thickening Ratio = Diaphragm Thickness at the end of a quiet expiration/ Diaphragm thickness at the end of a quiet inspiration.
Time frame: within 3 months after ICU discharge
M-mode Diaphragm Ultrasound imaging will be performed to measure diaphragm excursion during deep breathing defined as the displacement (centimetres) of the diaphragm between Functional Residual Capacity and Total Lung Capacity
Time frame: within 6 months after ICU discharge
M-mode Diaphragm Ultrasound imaging will be performed to measure diaphragm excursion during deep breathing defined as the displacement (centimetres) of the diaphragm between Functional Residual Capacity and Total Lung Capacity.
Time frame: within 3 months after ICU discharge
It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.
Time frame: within 6 months after ICU discharge
It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.
Time frame: within 3 months following ICU discharge
Dyspnea will be measured with the mMRC Dyspnea scale (range: 0-4, higher values indicating higher level of dyspnea)
Time frame: within 6 months following ICU discharge
Dyspnea will be measured with the mMRC Dyspnea scale (range: 0-4, higher values indicating higher level of dyspnea)
Time frame: within 3 months following ICU discharge
The 6MWT will be used to measure exercise capacity
Time frame: within 6 months following ICU discharge
The 6MWT will be used to measure exercise capacity
Time frame: within 3 months following ICU dischargemonths following ICU discharge
The SGRQ is used to measure health-related quality of life (range: 0-100, higher scores represent higher impairment in quality of life)
Time frame: within 6 months following ICU dischargemonths following ICU discharge
The SGRQ is used to measure health-related quality of life (range: 0-100, higher scores represent higher impairment in quality of life)
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Other
Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients After ICU Discharge: a 6 Months Follow-up Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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