Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal50 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Covid19

Interventions

Data collection and clinical testing of subjectsOTHER

6-months follow-up with clinical testing at 3 and 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

ICU. Ramón y Cajal University Hospital

Madrid, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.