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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection and clinical testing of subjects | Other | 6-months follow-up with clinical testing at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20) | It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles. | < 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. | within 6 months after ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 3 months after ICU discharge |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| LuÃs López-González, BSc,MSc | Fundación Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU. Ramón y Cajal University Hospital | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| 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. |
| 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. | 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. | 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 | 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. | 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. | 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. | 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) | 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) | within 6 months following ICU discharge |
| 6-Minutes Walk Test (6MWT) (metres) | The 6MWT will be used to measure exercise capacity | within 3 months following ICU discharge |
| 6-Minutes Walk Test (6MWT) (metres) | The 6MWT will be used to measure exercise capacity | 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) | 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) | within 6 months following ICU dischargemonths following ICU discharge |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |