Covid19NCT04853940
Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients
An observational study of Covid19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Data collection and clinical testing of subjects
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ⋧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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Covid19
- Being tested
- Data collection and clinical testing of subjects
- Keywords
- COVID19, Diaphragm ultrasound, Respiratory muscle strength, Dyspnea, Exercise Capacity, Quality of life, Post-ICU outcomes
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and clinical testing of subjectsOther
6-months follow-up with clinical testing at 3 and 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
Measured: < 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.
Measured: within 6 months after ICU discharge
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: within 6 months following ICU discharge
6-Minutes Walk Test (6MWT) (metres)
The 6MWT will be used to measure exercise capacity
Measured: within 3 months following ICU discharge
6-Minutes Walk Test (6MWT) (metres)
The 6MWT will be used to measure exercise capacity
Measured: 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)
Measured: 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)
Measured: within 6 months following ICU dischargemonths following ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jan 2021
- Primary completion30 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Natividad Seisdedos Nunez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- Luís López-González, BSc,MSc, Principal investigator, Fundación Ramón y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853940
- Sponsor's protocol ID
- 419/20
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853940
- Acronym / sponsor ID
- 419/20
- Conditions
- Covid19
- Keywords
- COVID19, Diaphragm ultrasound, Respiratory muscle strength, Dyspnea, Exercise Capacity, Quality of life, Post-ICU outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- ⋧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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection and clinical testing of subjects6-months follow-up with clinical testing at 3 and 6 months | Other | – |
Primary outcome
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.
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.
14 secondary outcomes
Diaphragm Thickening Ratio during deep breathing (centimetres)
Time frame: within 3 months after ICU discharge
Diaphragm Thickening Ratio during deep breathing (centimetres)
Time frame: within 6 months after ICU discharge
Diaphragm Thickening Ratio during quiet breathing (centimetres)
Time frame: within 3 months after ICU discharge
Diaphragm Thickening Ratio during quiet breathing (centimetres)
Time frame: within 6 months after ICU discharge
Diaphragm Excursion during deep breathing (centimetres)
Time frame: within 3 months after ICU discharge
Diaphragm Excursion during deep breathing (centimetres)
Time frame: within 6 months after ICU discharge
Maximal Expiratory Pressure (MEP) (cmH20)
Time frame: within 3 months after ICU discharge
Maximal Expiratory Pressure (MEP) (cmH20)
Time frame: within 6 months after ICU discharge
Modified Medical Research Council (mMRC) Dyspnea score
Time frame: within 3 months following ICU discharge
Modified Medical Research Council (mMRC) Dyspnea score
Time frame: within 6 months following ICU discharge
6-Minutes Walk Test (6MWT) (metres)
Time frame: within 3 months following ICU discharge
6-Minutes Walk Test (6MWT) (metres)
Time frame: within 6 months following ICU discharge
Saint George's Respiratory Questionnaire (SGRQ) score
Time frame: within 3 months following ICU dischargemonths following ICU discharge
Saint George's Respiratory Questionnaire (SGRQ) score
Time frame: within 6 months following ICU dischargemonths following ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luís López-González, BSc,MSc principal investigator
Fundación Ramón y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20) (time frame: < 3 months after ICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.