Diaphragmatic Echography in COVID-19 Pneumonia

Covid19 Clinical Trial

— COVIDUSDIAP  

Official title:

Prognostic Value of Transthoracic Diaphragmatic Echography in COVID-19 Pneumonia Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805579
• Other study ID #: ROYO1
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: April 2023
• Source: Aragon Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pneumonia
• Pneumonia, Viral
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Diaphragmatic echography
Diaphragmatic echography

Locations

Country	Name	City	State
Spain	Javier Lázaro Sierra	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Javier Lázaro	Sociedad Aragonesa de Patología del Aparato Respiratorio

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From date of inclusion until discharge date (lenght of hospitalization)
Secondary	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.	From date of inclusion until discharge date (lenght of hospitalization)