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Completed

NCT Number: NCT05805579

Diaphragmatic Echography in COVID-19 Pneumonia

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.

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Key information

Conditions

Pneumonia, Viral COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia RNA Virus Infections Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Javier Lázaro Sierra

Zaragoza, 50001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Diaphragmatic echography

Diagnostic Test

Diaphragmatic echography

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 strenght is directly related to thickness. The impact of COVID19 infection on this specific measure can predict patient evolution.

  2. 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)

    Diaphragm fatigability is directly related to movility. The impact of COVID19 infection on this specific measure can predict patient evolution.

Sponsors and collaborators

Lead sponsor

Javier Lázaro

Other

Collaborators

  • Sociedad Aragonesa de Patología del Aparato Respiratorio

Registry information

Official study title

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

Acronym: COVIDUSDIAP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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