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

Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients After ICU Discharge: a 6 Months Follow-up Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Data collection and clinical testing of subjects

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • ICU. Ramón y Cajal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Luís López-González, BSc,MSc, Fundación Ramón y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 17, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Exercise Capacity; COVID19; Dyspnea; Diaphragm ultrasound; Respiratory muscle strength; Post-ICU outcomes
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Dyspnea
• Other Study ID Numbers: 419/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED