Clinical trial NCT05805579: Diaphragmatic Echography in COVID-19 Pneumonia
Official title: Prognostic Value of Transthoracic Diaphragmatic Echography in COVID-19 Pneumonia Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Viral
Covid19
Respiratory Failure
Keywords: COVID19 pneumonia
Diaphragm ultrasound
Lead sponsor: Aragon Institute of Health Sciences
Sponsor class: OTHER
Collaborators: name: Sociedad Aragonesa de Patología del Aparato Respiratorio
First posted: 2023-04-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People hospitalaised in pulmonology service

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Early diaphragm ultrasound as a predictor factor for invasive and non invasive ventilation and death
timeFrame: From date of inclusion until discharge date (lenght of hospitalization)
Secondary outcomes:
measure: Diaphragm thickness rate as a predictor factor for invasive and non invasive ventilation and death
timeFrame: From date of inclusion until discharge date (lenght of hospitalization)
measure: Diaphragm movility rate as a predictor factor for invasive and non invasive ventilation and death
timeFrame: From date of inclusion until discharge date (lenght of hospitalization)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Javier Lázaro Sierra
Study officials:
References:
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.
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.
citation: Schepens T, Fard S, Goligher EC. Assessing Diaphragmatic Function. Respir Care. 2020 Jun;65(6):807-819. doi: 10.4187/respcare.07410.
citation: 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.