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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853940
• Other study ID #: 419/20
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dyspnea

Intervention

Other:
• Data collection and clinical testing of subjects
6-months follow-up with clinical testing at 3 and 6 months

Locations

Country	Name	City	State
Spain	ICU. Ramón y Cajal University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	6-Minutes Walk Test (6MWT) (metres)	The 6MWT will be used to measure exercise capacity	within 3 months following ICU discharge
Secondary	6-Minutes Walk Test (6MWT) (metres)	The 6MWT will be used to measure exercise capacity	within 6 months following ICU discharge
Secondary	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
Secondary	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