Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853940
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Natividad Seisdedos Nunez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Covid19 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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: < 6 months after ICU discharge ]
    It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.


Secondary Outcome Measures :
  1. Diaphragm Thickening Ratio during deep breathing (centimetres) [ Time Frame: < 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: < 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: < 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: < 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: < 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: < 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: < 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: < 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: < 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: < 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: < 3 months following ICU discharge ]
    The 6MWT will be used to measure exercise capacity

  12. 6-Minutes Walk Test (6MWT) (metres) [ Time Frame: < 6 months following ICU discharge ]
    The 6MWT will be used to measure exercise capacity

  13. Saint George's Respiratory Questionnaire (SGRQ) score [ Time Frame: < 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: < 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853940


Contacts
Layout table for location contacts
Contact: Maria-Natividad Seisdedos-Nuñez, BSc,MSc 0034913368000 ext 8250 marianatividad.seisdedos@salud.madrid.org

Locations
Layout table for location information
Spain
ICU. Ramón y Cajal University Hospital Recruiting
Madrid, Spain, 28034
Contact: Maria-Natividad Seisdedos-Núñez, PT, MSc    0034913368000 ext 8250    marianatividad.seisdedos@salud.madrid.org   
Contact: Luís López-González, PT,MSc    0034913368000 ext 8250    luislopezgonzalez4@gmail.com   
Sub-Investigator: Irene Lázaro Navas, BSc, MSc, PhD         
Sub-Investigator: David Valcarcel Linares, BSc, MScc         
Sub-Investigator: Teresa Gómez González, Bec,         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
Layout table for investigator information
Principal Investigator: Luís López-González, PT, MSc Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Maria Natividad Seisdedos Nunez, Senior Physiotherapist, MSc, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT04853940    
Other Study ID Numbers: 419/20
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maria Natividad Seisdedos Nunez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
COVID19
Diaphragm ultrasound
Respiratory muscle strength
Dyspnea
 Exercise Capacity
Quality of life
Post-ICU outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Dyspnea
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory