Pneumonia, ViralCOVIDUSDIAPNCT05805579
Diaphragmatic Echography in COVID-19 Pneumonia
An observational study of Pneumonia, Viral and Covid19, run by Javier Lázaro at 1 site in Spain.
Trial summary
We hypothesized that diaphragm thickness is concerned in acute respiratory failure of COVID19 patients and its ultrasound measure at the begining of hospitalisation is a good predictor of poor outcome. A prospective observational non intervention study is designed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia, Viral, Covid19, Respiratory Failure
- What is being tested?
- Diaphragmatic echography
- How many people
- 171 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 20 Jun 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People hospitalaised in pulmonology service
Who may be able to join
- COVID19 Pneumonia Acute respiratory failure (PaO2 <60mmHg)
Who cannot join
- Invasive or non invasive ventilation within first 24h Neuromuscular disease Diaphragmatic paralysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Transthoracic Diaphragmatic Echography in COVID-19 Pneumonia Patients With Acute Respiratory Failure
We hypothesized that diaphragm thickness is concerned in acute respiratory failure of COVID19 patients and its ultrasound measure at the begining of hospitalisation is a good predictor of poor outcome.
A prospective observational non intervention study is designed.
Read the detailed description
To answer our hypothesis we will perform diaphragm ultrasound in the first 24hr hospitalized COVID19 patients.
In the ultrasound exploration we will assess diaphragm movility and thickness. We will also assess other clinical, biochemistry and radiological variables. The main outcome we want to analyze is the destination on discharge: home, respiratory intermediate critical unit or exitus.
- Conditions
- Pneumonia, Viral, Covid19, Respiratory Failure
- Being tested
- Diaphragmatic echography
- Keywords
- COVID19 pneumonia, Diaphragm ultrasound
- Medical subject headings
- Pneumonia, Viral, COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic echographyDiagnostic test
Diaphragmatic echography
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diaphragm ultrasound as a predictor factor for invasive and non invasive ventilation and death
This is the main outcome of our study given that it has a important clinical implications. If we confirm our hypothesis diaphragm ultrasound could prove to be a useful prognosis tool for COVID19 patients.
Measured: From date of inclusion until discharge date (lenght of hospitalization)
Secondary outcomes (2)
Diaphragm thickness rate as a predictor factor for invasive and non invasive ventilation and death
Diaphragm strenght is directly related to thickness. The impact of COVID19 infection on this specific measure can predict patient evolution.
Measured: From date of inclusion until discharge date (lenght of hospitalization)
Diaphragm movility rate as a predictor factor for invasive and non invasive ventilation and death
Diaphragm fatigability is directly related to movility. The impact of COVID19 infection on this specific measure can predict patient evolution.
Measured: From date of inclusion until discharge date (lenght of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Feb 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Lázaro
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Aragonesa de Patología del Aparato Respiratorio
- Responsible party
- Sponsor-investigator, Javier Lázaro, Aragon Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805579
- Sponsor's protocol ID
- ROYO1
- Acronym
- COVIDUSDIAP
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All investigators that can use these data are included as collaborators. Sharing that type of information is forbiden by our ethics comitee
Publications
Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.
PubMed 29703214Pivetta E, Cara I, Paglietta G, Scategni V, Labarile G, Tizzani M, Porrino G, Locatelli S, Calzolari G, Morello F, Maule MM, Lupia E. Diaphragmatic Point-of-Care Ultrasound in COVID-19 Patients in the Emergency Department-A Proof-of-Concept Study. J Clin Med. 2021 Nov 14;10(22):5291. doi: 10.3390/jcm10225291.
PubMed 34830573Schepens T, Fard S, Goligher EC. Assessing Diaphragmatic Function. Respir Care. 2020 Jun;65(6):807-819. doi: 10.4187/respcare.07410.
PubMed 32457172Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
PubMed 19017880Lazaro Sierra J, Doz Arcas M, Claveria Marco P, Rosell Abos MT, Santolaria Lopez MA, Perez Gimenez L, Lanzuela Benedicto T, Zuil Martin M, Boldova Loscertales A, Garcia Saez S, Huertas Puyuelo A, Nieto Sanchez D, Carretero Garcia JA. Prognostic Value of Diaphragmatic Ultrasound in Patients Admitted for COVID-19 Pneumonia. Open Respir Arch. 2023 Dec 1;6(1):100290. doi: 10.1016/j.opresp.2023.100290. eCollection 2024 Jan-Mar.
PubMed 38293643
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Transthoracic Diaphragmatic Echography in COVID-19 Pneumonia Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT05805579
- Acronym / sponsor ID
- COVIDUSDIAP / ROYO1
- Conditions
- Pneumonia, Viral, Covid19, Respiratory Failure
- Keywords
- COVID19 pneumonia, Diaphragm ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Javier LázaroUniversity, hospital or other
- Collaborators
- Sociedad Aragonesa de Patología del Aparato Respiratorio
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 10 Apr 2023 (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.
We hypothesized that diaphragm thickness is concerned in acute respiratory failure of COVID19 patients and its ultrasound measure at the begining of hospitalisation is a good predictor of poor outcome.
A prospective observational non intervention study is designed.
Detailed description
To answer our hypothesis we will perform diaphragm ultrasound in the first 24hr hospitalized COVID19 patients.
In the ultrasound exploration we will assess diaphragm movility and thickness. We will also assess other clinical, biochemistry and radiological variables. The main outcome we want to analyze is the destination on discharge: home, respiratory intermediate critical unit or exitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People hospitalaised in pulmonology service
Key inclusion criteria (1 listed)
- COVID19 Pneumonia Acute respiratory failure (PaO2 <60mmHg)
Key exclusion criteria (1 listed)
- Invasive or non invasive ventilation within first 24h Neuromuscular disease Diaphragmatic paralysis
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 |
|---|---|---|
| Diaphragmatic echographyDiaphragmatic echography | Diagnostic test | – |
Primary outcome
Early diaphragm ultrasound as a predictor factor for invasive and non invasive ventilation and death
Time frame: From date of inclusion until discharge date (lenght of hospitalization)
This is the main outcome of our study given that it has a important clinical implications. If we confirm our hypothesis diaphragm ultrasound could prove to be a useful prognosis tool for COVID19 patients.
2 secondary outcomes
Diaphragm thickness rate as a predictor factor for invasive and non invasive ventilation and death
Time frame: From date of inclusion until discharge date (lenght of hospitalization)
Diaphragm movility rate as a predictor factor for invasive and non invasive ventilation and death
Time frame: From date of inclusion until discharge date (lenght of hospitalization)
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 10 Apr 2023.
- Background: PubMed 29703214Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbi L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.
- Background: PubMed 34830573Pivetta E, Cara I, Paglietta G, Scategni V, Labarile G, Tizzani M, Porrino G, Locatelli S, Calzolari G, Morello F, Maule MM, Lupia E. Diaphragmatic Point-of-Care Ultrasound in COVID-19 Patients in the Emergency Department-A Proof-of-Concept Study. J Clin Med. 2021 Nov 14;10(22):5291. doi: 10.3390/jcm10225291.
- Background: PubMed 32457172Schepens T, Fard S, Goligher EC. Assessing Diaphragmatic Function. Respir Care. 2020 Jun;65(6):807-819. doi: 10.4187/respcare.07410.
- Background: PubMed 19017880Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
- Derived from this study: PubMed 38293643Lazaro Sierra J, Doz Arcas M, Claveria Marco P, Rosell Abos MT, Santolaria Lopez MA, Perez Gimenez L, Lanzuela Benedicto T, Zuil Martin M, Boldova Loscertales A, Garcia Saez S, Huertas Puyuelo A, Nieto Sanchez D, Carretero Garcia JA. Prognostic Value of Diaphragmatic Ultrasound in Patients Admitted for COVID-19 Pneumonia. Open Respir Arch. 2023 Dec 1;6(1):100290. doi: 10.1016/j.opresp.2023.100290. eCollection 2024 Jan-Mar.
- Individual participant dataSharing planned: No. All investigators that can use these data are included as collaborators. Sharing that type of information is forbiden by our ethics comitee
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pneumonia, Viral and Covid19, run by Javier Lázaro 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 1 inclusion and 1 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 10 Apr 2023. 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?
Early diaphragm ultrasound as a predictor factor for invasive and non invasive ventilation and death (time frame: From date of inclusion until discharge date (lenght of hospitalization)). 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 NCT05805579, which also lists 5 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 10 Apr 2023.