Inspiratory Effort in COVID-19 (PERSIA)

April 24, 2025 updated by: Roberto Tonelli, University of Modena and Reggio Emilia

Inspiratory Effort Assessment in Patients With COVID-19 Pneumonia Undergoing Non Invasive Respiratory Support

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena for acute respiratory failure due to COVID-19 pneumonia and candidate to non invasive respiratory support

Description

Inclusion Criteria:

  • COVID-19
  • Acute respiratory failure undergoing non-invasive respiratory support

Exclusion Criteria:

  • Need for immediate endotracheal intubation
  • Chronic respiratory diseases

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
Inspiratory effort quantification
Time Frame: 24 hours from admission
Esophageal pressure assessment through dedicated esophageal pressure transducer
24 hours from admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non invasive respiratory support failure
Time Frame: 24 hours
Reaching of the criteria for endotracheal intubation
24 hours

Collaborators and Investigators

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

Sponsor

University of Modena and Reggio Emilia

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)

March 1, 2020

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UModenaReggio17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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