Diaphragmatic Echography in COVID-19 Pneumonia

NCT05805579 | Completed

• 1 other identifier: ROYO1
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia, Viral; Covid19; Respiratory Failure

Keywords

COVID19 pneumonia; Diaphragm ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  From date of inclusion until discharge date (lenght of hospitalization)

Interventions

Diaphragmatic echography DIAGNOSTIC_TEST

Diaphragmatic echography

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People hospitalaised in pulmonology service

You may qualify if:

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

You may not qualify if:

• Invasive or non invasive ventilation within first 24h Neuromuscular disease Diaphragmatic paralysis

Sponsors & Collaborators

• Javier Lázaro: lead
• Sociedad Aragonesa de Patología del Aparato Respiratorio: collaborator

Study Sites (1)

Javier Lázaro Sierra

Zaragoza, 50001, Spain

Location

Related Publications (5)

• 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.

  PMID: 29703214 BACKGROUND

• 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.

  PMID: 34830573 BACKGROUND

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

  PMID: 32457172 BACKGROUND

• 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.

  PMID: 19017880 BACKGROUND

• 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.

  PMID: 38293643 DERIVED

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 10, 2023
• Study Start: February 1, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)