Diaphragmatic Echography in COVID-19 Pneumonia

Completed

• Conditions: Pneumonia, Viral; Covid19; Respiratory Failure

• Registration Number: NCT05805579
• Lead Sponsor: Javier Lázaro

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-06-20
• Study Completion: 2021-06-20
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early diaphragm ultrasound as a predictor factor for invasive and non invasive ventilation and death	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 Outcome Measures

Name	Time	Method
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 strenght is directly related to thickness. The impact of COVID19 infection on this specific measure can predict patient evolution.
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)	Diaphragm fatigability is directly related to movility. The impact of COVID19 infection on this specific measure can predict patient evolution.

Trial Locations

Locations (1)

Javier Lázaro Sierra; 🇪🇸 Zaragoza, Spain