An observational study in Covid19, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Observational
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.
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 50 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 82 studies on the registry; 21 are open to participants now.
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Patients diagnosed with COVID19 pneumonia who are discharged from the Ramón y Cajal University Hospital ICU from 1 October 2020 to 28 February 2021 will be eligible for the study
Exclusion Criteria:
6-months follow-up with clinical testing at 3 and 6 months
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Time frame: < 3 months after ICU discharge
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Time frame: within 6 months after ICU discharge
Diaphragm Thickening Ratio during deep breathing (centimetres)
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
Diaphragm Thickening Ratio during deep breathing (centimetres)
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
Diaphragm Thickening Ratio during quiet breathing (centimetres)
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
Diaphragm Thickening Ratio during quiet breathing (centimetres)
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
Diaphragm Excursion during deep breathing (centimetres)
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
Diaphragm Excursion during deep breathing (centimetres)
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
Maximal Expiratory Pressure (MEP) (cmH20)
It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.
Time frame: within 3 months after ICU discharge
Maximal Expiratory Pressure (MEP) (cmH20)
It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.
Time frame: within 6 months after ICU discharge
Modified Medical Research Council (mMRC) Dyspnea score
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
Modified Medical Research Council (mMRC) Dyspnea score
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
6-Minutes Walk Test (6MWT) (metres)
The 6MWT will be used to measure exercise capacity
Time frame: within 3 months following ICU discharge
6-Minutes Walk Test (6MWT) (metres)
The 6MWT will be used to measure exercise capacity
Time frame: within 6 months following ICU discharge
Saint George's Respiratory Questionnaire (SGRQ) score
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 3 months following ICU dischargemonths following ICU discharge
Saint George's Respiratory Questionnaire (SGRQ) score
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
Plan to share: Undecided
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal