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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04666246
Other study ID # UModenaReggio17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date February 1, 2023

Study information

Verified date October 2021
Source University of Modena and Reggio Emilia
Contact Roberto Tonelli, MD
Phone 0039 0594225934
Email roberto.tonelli@me.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 1, 2023
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - COVID-19 - Acute respiratory failure undergoing non-invasive respiratory support Exclusion Criteria: - Need for immediate endotracheal intubation - Chronic respiratory diseases

Study Design


Locations

Country Name City State
Italy University Hospital of Modena Modena

Sponsors (1)

Lead Sponsor Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inspiratory effort quantification Esophageal pressure assessment through dedicated esophageal pressure transducer 24 hours from admission
Secondary Non invasive respiratory support failure Reaching of the criteria for endotracheal intubation 24 hours
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