Clinical trial NCT04853940: Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID19
Diaphragm ultrasound
Respiratory muscle strength
Dyspnea
Exercise Capacity
Quality of life
Post-ICU outcomes
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Primary outcomes:
measure: Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
timeFrame: < 3 months after ICU discharge
measure: Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
timeFrame: within 6 months after ICU discharge
Secondary outcomes:
measure: Diaphragm Thickening Ratio during deep breathing (centimetres)
timeFrame: within 3 months after ICU discharge
measure: Diaphragm Thickening Ratio during deep breathing (centimetres)
timeFrame: within 6 months after ICU discharge
measure: Diaphragm Thickening Ratio during quiet breathing (centimetres)
timeFrame: within 3 months after ICU discharge
measure: Diaphragm Thickening Ratio during quiet breathing (centimetres)
timeFrame: within 6 months after ICU discharge
measure: Diaphragm Excursion during deep breathing (centimetres)
timeFrame: within 3 months after ICU discharge
measure: Diaphragm Excursion during deep breathing (centimetres)
timeFrame: within 6 months after ICU discharge
measure: Maximal Expiratory Pressure (MEP) (cmH20)
timeFrame: within 3 months after ICU discharge
measure: Maximal Expiratory Pressure (MEP) (cmH20)
timeFrame: within 6 months after ICU discharge
measure: Modified Medical Research Council (mMRC) Dyspnea score
timeFrame: within 3 months following ICU discharge
measure: Modified Medical Research Council (mMRC) Dyspnea score
timeFrame: within 6 months following ICU discharge
measure: 6-Minutes Walk Test (6MWT) (metres)
timeFrame: within 3 months following ICU discharge
measure: 6-Minutes Walk Test (6MWT) (metres)
timeFrame: within 6 months following ICU discharge
measure: Saint George's Respiratory Questionnaire (SGRQ) score
timeFrame: within 3 months following ICU dischargemonths following ICU discharge
measure: Saint George's Respiratory Questionnaire (SGRQ) score
timeFrame: within 6 months following ICU dischargemonths following ICU discharge
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: ICU. Ramón y Cajal University Hospital
Study officials:
affiliation: Fundación Ramón y Cajal
name: Luís López-González, BSc,MSc
role: PRINCIPAL_INVESTIGATOR
References: