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NCT Number: NCT04853940

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection and clinical testing of subjects

Other

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

Primary outcomes

  1. Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)

    Time frame: < 3 months after ICU discharge

    It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.

  2. Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)

    Time frame: within 6 months after ICU discharge

    It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.

Secondary outcomes

  1. Diaphragm Thickening Ratio during deep breathing (centimetres)

    Time frame: within 3 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.

  2. Diaphragm Thickening Ratio during deep breathing (centimetres)

    Time frame: 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.

  3. Diaphragm Thickening Ratio during quiet breathing (centimetres)

    Time frame: within 3 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.

  4. Diaphragm Thickening Ratio during quiet breathing (centimetres)

    Time frame: 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.

  5. Diaphragm Excursion during deep breathing (centimetres)

    Time frame: within 3 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

  6. Diaphragm Excursion during deep breathing (centimetres)

    Time frame: 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.

  7. Maximal Expiratory Pressure (MEP) (cmH20)

    Time frame: within 3 months after ICU discharge

    It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.

  8. Maximal Expiratory Pressure (MEP) (cmH20)

    Time frame: within 6 months after ICU discharge

    It is the greater pressure which may be generated during maximal expiration by the inspiratory muscles.

  9. Modified Medical Research Council (mMRC) Dyspnea score

    Time frame: within 3 months following ICU discharge

    Dyspnea will be measured with the mMRC Dyspnea scale (range: 0-4, higher values indicating higher level of dyspnea)

  10. Modified Medical Research Council (mMRC) Dyspnea score

    Time frame: 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)

  11. 6-Minutes Walk Test (6MWT) (metres)

    Time frame: within 3 months following ICU discharge

    The 6MWT will be used to measure exercise capacity

  12. 6-Minutes Walk Test (6MWT) (metres)

    Time frame: within 6 months following ICU discharge

    The 6MWT will be used to measure exercise capacity

  13. Saint George's Respiratory Questionnaire (SGRQ) score

    Time frame: within 3 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)

  14. Saint George's Respiratory Questionnaire (SGRQ) score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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