Diaphragmatic Echography in COVID-19 Pneumonia

NCT ID: NCT05805579

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia, Viral Covid19 Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diaphragmatic echography

Diaphragmatic echography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* COVID19 Pneumonia Acute respiratory failure (PaO2 \<60mmHg)

Exclusion Criteria

* Invasive or non invasive ventilation within first 24h Neuromuscular disease Diaphragmatic paralysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sociedad Aragonesa de Patología del Aparato Respiratorio

UNKNOWN

Sponsor Role collaborator

Javier Lázaro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Javier Lázaro

MD; PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Javier Lázaro Sierra

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29703214 (View on PubMed)

Pivetta 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.

Reference Type BACKGROUND
PMID: 34830573 (View on PubMed)

Schepens T, Fard S, Goligher EC. Assessing Diaphragmatic Function. Respir Care. 2020 Jun;65(6):807-819. doi: 10.4187/respcare.07410.

Reference Type BACKGROUND
PMID: 32457172 (View on PubMed)

Boussuges 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.

Reference Type BACKGROUND
PMID: 19017880 (View on PubMed)

Lazaro 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.

Reference Type DERIVED
PMID: 38293643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROYO1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.