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

Completed

• Conditions: Covid19

• Registration Number: NCT04853940
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-22
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)	within 6 months after ICU discharge	It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.

Secondary Outcome Measures

Name	Time	Method
Diaphragm Thickening Ratio during quiet breathing (centimetres)	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.
Saint George's Respiratory Questionnaire (SGRQ) score	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)
Diaphragm Thickening Ratio during deep breathing (centimetres)	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.
Modified Medical Research Council (mMRC) Dyspnea score	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)
Maximal Expiratory Pressure (MEP) (cmH20)	within 6 months after ICU discharge	It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.
6-Minutes Walk Test (6MWT) (metres)	within 6 months following ICU discharge	The 6MWT will be used to measure exercise capacity
Diaphragm Excursion during deep breathing (centimetres)	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.

Trial Locations

Locations (1)

ICU. Ramón y Cajal University Hospital; 🇪🇸 Madrid, Spain