Diaphragmatic Echography in COVID-19 Pneumonia (COVIDUSDIAP)

April 7, 2023 updated by: Javier Lázaro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50001
        • Javier Lázaro Sierra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People hospitalaised in pulmonology service

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until discharge date (lenght of hospitalization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From date of inclusion until discharge date (lenght of hospitalization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javier Lázaro

Collaborators

Sociedad Aragonesa de Patología del Aparato Respiratorio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

June 20, 2021

Study Completion (Actual)

June 20, 2021

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROYO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All investigators that can use these data are included as collaborators. Sharing that type of information is forbiden by our ethics comitee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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