COPDEDIFEBNCT04509128
Ultrasonographic Evaluation of Diaphragm and Quadriceps in Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of COPD and COPD Exacerbation, run by IRCCS San Raffaele Roma.
Trial summary
The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group A: Subjects hospitalizated for a COPD acute exacerbation Group B: Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation.
Who may be able to join
- COPD diagnosis
- previous or actual cigarette smoking history
- COPD exacerbation requiring hospitalization
- Obtained written informed consent
- COPD diagnosis
- previous or actual cigarette smoking history
Show all 9Show fewer
- COPD exacerbation requiring hospitalization in the previous 30 days
- Indication to undergo a pulmonary rehabilitation protocol
- Obtained written informed consent
Who cannot join
- Pleural effusion extended for more than two intercostal spaces
- Interstitial lung diseases
- Major surgery in the previous 30 days
- Right pleurodesis or fibrothorax
- Right stroke outcomes
- Technical impossibility to perform ultrasound evaluations
Show all 16Show fewer
- conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
- Absence of written informed consent
- Pleural effusion extended for more than two intercostal spaces
- Interstitial lung diseases
- Major surgery in the previous 30 days
- Right pleurodesis or fibrothorax
- Right stroke outcomes
- Technical impossibility to perform ultrasound evaluations
- conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
- Absence of written informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Echographic Characteristics of DIaphragm and FEmoral Quadriceps in COPD Patients: Evaluation of Their Relationship With the Lung Function Impairment and the Effect of Pulmonary Rehabilitation
The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation.
Specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative US parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by US, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative US parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative US parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.
- Conditions
- COPD, COPD Exacerbation
- Keywords
- Multidimensional evaluation, COPD, Pulmonary rehabilitation, Diaphragmatic ultrasound, Vastus lateralis muscle ultrasound
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Subjects hospitalized for a COPD acute exacerbation, undergoing arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, at admission and discharge. | |
| B | Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation, undergoing pulmonary function test, arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, before and after PR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data
Evaluation of the correlation between qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and the degree of respiratory function impairment
Measured: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation
Evaluation of the post rehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function
Measured: After 4 weeks of Pulmonary Rehabilitation (T1)
Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness
Evaluation of the correlation between post rehabilitation qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and indicators of pulmonary rehabilitation treatment effectiveness (mMRC, Modified Medical Research Council, Dyspnea Scale; distance in meters at six minute walking test; respiratory function data; arterial blood gas values)
Measured: After 4 weeks of Pulmonary Rehabilitation (T1)
Secondary outcomes (5)
Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function
Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict in-hospital mortality
Measured: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Prediction of length of stay by means of parameters of diaphragmatic and vastus lateralis muscle function
Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict length of stay
Measured: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Evaluation the ability of qualitative and quantitative US parameters to predict COPD exacerbation rate six months after the discharge
Measured: Six months after discharge (T2)
Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Evaluation the ability of qualitative and quantitative US parameters to predict hospitalization rate six months after the discharge
Measured: Six months after discharge (T2)
Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Evaluation the ability of qualitative and quantitative US parameters to predict mortality rate six months after the discharge
Measured: Six months after discharge (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vittoria Conti, PhD, Principal investigator, Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509128
- Sponsor's protocol ID
- RP 19/19
- Acronym
- EDIFEB
- Status last verified
- Jun 2023
- First submitted
- 3 Aug 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
Decramer M, De Benedetto F, Del Ponte A, Marinari S. Systemic effects of COPD. Respir Med. 2005 Dec;99 Suppl B:S3-10. doi: 10.1016/j.rmed.2005.09.010. Epub 2005 Oct 10.
PubMed 16219454Koerts-de Lang E, Schols AM, Rooyackers OE, Gayan-Ramirez G, Decramer M, Wouters EF. Different effects of corticosteroid-induced muscle wasting compared with undernutrition on rat diaphragm energy metabolism. Eur J Appl Physiol. 2000 Aug;82(5-6):493-8. doi: 10.1007/s004210000231.
PubMed 10985606Decramer M, Lacquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994 Jul;150(1):11-6. doi: 10.1164/ajrccm.150.1.8025735.
PubMed 8025735Sabino PG, Silva BM, Brunetto AF. Nutritional status is related to fat-free mass, exercise capacity and inspiratory strength in severe chronic obstructive pulmonary disease patients. Clinics (Sao Paulo). 2010 Jun;65(6):599-605. doi: 10.1590/S1807-59322010000600007.
PubMed 20613936Marquis K, Debigare R, Lacasse Y, LeBlanc P, Jobin J, Carrier G, Maltais F. Midthigh muscle cross-sectional area is a better predictor of mortality than body mass index in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 15;166(6):809-13. doi: 10.1164/rccm.2107031.
PubMed 12231489Montes de Oca M, Torres SH, Gonzalez Y, Romero E, Hernandez N, Mata A, Talamo C. Peripheral muscle composition and health status in patients with COPD. Respir Med. 2006 Oct;100(10):1800-6. doi: 10.1016/j.rmed.2006.01.020. Epub 2006 Mar 20.
PubMed 16545558Thurlbeck WM. Diaphragm and body weight in emphysema. Thorax. 1978 Aug;33(4):483-7. doi: 10.1136/thx.33.4.483.
PubMed 694801Arora NS, Rochester DF. Effect of body weight and muscularity on human diaphragm muscle mass, thickness, and area. J Appl Physiol Respir Environ Exerc Physiol. 1982 Jan;52(1):64-70. doi: 10.1152/jappl.1982.52.1.64.
PubMed 7061279Rochester DF. The diaphragm: contractile properties and fatigue. J Clin Invest. 1985 May;75(5):1397-402. doi: 10.1172/JCI111841. No abstract available.
PubMed 3889054Cesari M, Pedone C, Chiurco D, Cortese L, Conte ME, Scarlata S, Incalzi RA. Physical performance, sarcopenia and respiratory function in older patients with chronic obstructive pulmonary disease. Age Ageing. 2012 Mar;41(2):237-41. doi: 10.1093/ageing/afr167. Epub 2011 Dec 8. No abstract available.
PubMed 22156558Ticinesi A, Meschi T, Narici MV, Lauretani F, Maggio M. Muscle Ultrasound and Sarcopenia in Older Individuals: A Clinical Perspective. J Am Med Dir Assoc. 2017 Apr 1;18(4):290-300. doi: 10.1016/j.jamda.2016.11.013. Epub 2017 Feb 13.
PubMed 28202349Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012.
PubMed 24737560Cesari M, Landi F, Calvani R, Cherubini A, Di Bari M, Kortebein P, Del Signore S, Le Lain R, Vellas B, Pahor M, Roubenoff R, Bernabei R, Marzetti E; SPRINTT Consortium. Rationale for a preliminary operational definition of physical frailty and sarcopenia in the SPRINTT trial. Aging Clin Exp Res. 2017 Feb;29(1):81-88. doi: 10.1007/s40520-016-0716-1. Epub 2017 Feb 10.
PubMed 28188558Ticinesi A, Narici MV, Lauretani F, Nouvenne A, Colizzi E, Mantovani M, Corsonello A, Landi F, Meschi T, Maggio M. Assessing sarcopenia with vastus lateralis muscle ultrasound: an operative protocol. Aging Clin Exp Res. 2018 Dec;30(12):1437-1443. doi: 10.1007/s40520-018-0958-1. Epub 2018 Apr 26.
PubMed 29700758
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echographic Characteristics of DIaphragm and FEmoral Quadriceps in COPD Patients: Evaluation of Their Relationship With the Lung Function Impairment and the Effect of Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT04509128
- Acronym / sponsor ID
- EDIFEB / RP 19/19
- Conditions
- COPD, COPD Exacerbation
- Keywords
- Multidimensional evaluation, COPD, Pulmonary rehabilitation, Diaphragmatic ultrasound, Vastus lateralis muscle ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Aug 2020 (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.
The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation.
Specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative US parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by US, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative US parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative US parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subjects hospitalized for a COPD acute exacerbation, undergoing arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, at admission and discharge. |
| B | – | –Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation, undergoing pulmonary function test, arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, before and after PR. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group A: Subjects hospitalizated for a COPD acute exacerbation Group B: Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation.
Key inclusion criteria (9 listed)
- COPD diagnosis
- previous or actual cigarette smoking history
- COPD exacerbation requiring hospitalization
- Obtained written informed consent
- COPD diagnosis
Key exclusion criteria (16 listed)
- Pleural effusion extended for more than two intercostal spaces
- Interstitial lung diseases
- Major surgery in the previous 30 days
- Right pleurodesis or fibrothorax
- Right stroke outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data
Time frame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Evaluation of the correlation between qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and the degree of respiratory function impairment
Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation
Time frame: After 4 weeks of Pulmonary Rehabilitation (T1)
Evaluation of the post rehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function
Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness
Time frame: After 4 weeks of Pulmonary Rehabilitation (T1)
Evaluation of the correlation between post rehabilitation qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and indicators of pulmonary rehabilitation treatment effectiveness (mMRC, Modified Medical Research Council, Dyspnea Scale; distance in meters at six minute walking test; respiratory function data; arterial blood gas values)
5 secondary outcomes
Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function
Time frame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Prediction of length of stay by means of parameters of diaphragmatic and vastus lateralis muscle function
Time frame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Time frame: Six months after discharge (T2)
Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Time frame: Six months after discharge (T2)
Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function
Time frame: Six months after discharge (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 16219454Decramer M, De Benedetto F, Del Ponte A, Marinari S. Systemic effects of COPD. Respir Med. 2005 Dec;99 Suppl B:S3-10. doi: 10.1016/j.rmed.2005.09.010. Epub 2005 Oct 10.
- Background: PubMed 10985606Koerts-de Lang E, Schols AM, Rooyackers OE, Gayan-Ramirez G, Decramer M, Wouters EF. Different effects of corticosteroid-induced muscle wasting compared with undernutrition on rat diaphragm energy metabolism. Eur J Appl Physiol. 2000 Aug;82(5-6):493-8. doi: 10.1007/s004210000231.
- Background: PubMed 8025735Decramer M, Lacquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994 Jul;150(1):11-6. doi: 10.1164/ajrccm.150.1.8025735.
- Background: PubMed 20613936Sabino PG, Silva BM, Brunetto AF. Nutritional status is related to fat-free mass, exercise capacity and inspiratory strength in severe chronic obstructive pulmonary disease patients. Clinics (Sao Paulo). 2010 Jun;65(6):599-605. doi: 10.1590/S1807-59322010000600007.
- Background: PubMed 12231489Marquis K, Debigare R, Lacasse Y, LeBlanc P, Jobin J, Carrier G, Maltais F. Midthigh muscle cross-sectional area is a better predictor of mortality than body mass index in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 15;166(6):809-13. doi: 10.1164/rccm.2107031.
- Background: PubMed 16545558Montes de Oca M, Torres SH, Gonzalez Y, Romero E, Hernandez N, Mata A, Talamo C. Peripheral muscle composition and health status in patients with COPD. Respir Med. 2006 Oct;100(10):1800-6. doi: 10.1016/j.rmed.2006.01.020. Epub 2006 Mar 20.
- Background: PubMed 694801Thurlbeck WM. Diaphragm and body weight in emphysema. Thorax. 1978 Aug;33(4):483-7. doi: 10.1136/thx.33.4.483.
- Background: PubMed 7061279Arora NS, Rochester DF. Effect of body weight and muscularity on human diaphragm muscle mass, thickness, and area. J Appl Physiol Respir Environ Exerc Physiol. 1982 Jan;52(1):64-70. doi: 10.1152/jappl.1982.52.1.64.
- Background: PubMed 3889054Rochester DF. The diaphragm: contractile properties and fatigue. J Clin Invest. 1985 May;75(5):1397-402. doi: 10.1172/JCI111841. No abstract available.
- Background: PubMed 22156558Cesari M, Pedone C, Chiurco D, Cortese L, Conte ME, Scarlata S, Incalzi RA. Physical performance, sarcopenia and respiratory function in older patients with chronic obstructive pulmonary disease. Age Ageing. 2012 Mar;41(2):237-41. doi: 10.1093/ageing/afr167. Epub 2011 Dec 8. No abstract available.
- Background: PubMed 28202349Ticinesi A, Meschi T, Narici MV, Lauretani F, Maggio M. Muscle Ultrasound and Sarcopenia in Older Individuals: A Clinical Perspective. J Am Med Dir Assoc. 2017 Apr 1;18(4):290-300. doi: 10.1016/j.jamda.2016.11.013. Epub 2017 Feb 13.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelinesLink provided by the sponsor.
- 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.
Vittoria Conti, PhD principal investigator
Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and COPD Exacerbation, run by IRCCS San Raffaele Roma.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vittoria Conti, PhD (0039 338 2163293, vittoria.conti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data (time frame: At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509128, which also lists 26 linked publications.
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 22 Jun 2023.