Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients After ICU Discharge: a 6 Months Follow-up Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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
Investigators
Maria Natividad Seisdedos Nunez
Senior Physiotherapist, MSc
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Eligibility Criteria
Inclusion Criteria
- •⋧18 years old,
- •subjects diagnosed with COVID-19 confirmed by positive SARS-CoV-2 PCR testing who require admission to ICU for invasive mechanical ventilation
- •invasive ventilation \> 24 hours.
Exclusion Criteria
- •pre-existing cognitive impairment,
- •communication/language barrier
- •any concurrent physical or mental health condition/ impairment that prevents subjects from taking part in evaluations or providing informed consent
- •loss of independent walking ability (with or without walking aids) prior to hospitalisation defined by a score of ≤2 on the mobility item of the modified Barthel Index,
- •pregnancy,
- •any injuries/surgery that requires medical bed rest.
Outcomes
Primary Outcomes
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
Time Frame: within 6 months after ICU discharge
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Secondary Outcomes
- Diaphragm Thickening Ratio during quiet breathing (centimetres)(within 6 months after ICU discharge)
- Saint George's Respiratory Questionnaire (SGRQ) score(within 6 months following ICU dischargemonths following ICU discharge)
- Diaphragm Thickening Ratio during deep breathing (centimetres)(within 6 months after ICU discharge)
- Modified Medical Research Council (mMRC) Dyspnea score(within 6 months following ICU discharge)
- Maximal Expiratory Pressure (MEP) (cmH20)(within 6 months after ICU discharge)
- 6-Minutes Walk Test (6MWT) (metres)(within 6 months following ICU discharge)
- Diaphragm Excursion during deep breathing (centimetres)(within 6 months after ICU discharge)