Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure (TEMPO)

March 22, 2023 updated by: Alessandro Marchioni, University of Modena and Reggio Emilia
This study aims at assessing the correlation between trans esophageal pressure and related respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive respiratory support failure in patients with acute hypoxic respiratory failure of different etiology (including COVID-19).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

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 Locations

  • Italy
      • Modena, Italy, 41125
        • Recruiting
        • University Hospital of Modena Policlinico

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

See inclusion criteria

Description

Inclusion Criteria:

  • Age >18 years
  • Acute hypoxic respiratory failure (P/F < 200)

Exclusion Criteria:

  • Acute pulmonary edema
  • Chest wall deformities
  • Immediate need for Mechanical Ventilation
  • Pregnancy
  • Hypercapnic RF

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
Esophageal pressure impact on non invasive respiratory support (NRS) failure
Time Frame: 24 hours
Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transpulmonary pressure impact on NRS failure
Time Frame: 24 hours
Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure
24 hours
Dynamic compliance impact on NRS failure
Time Frame: 24 hours
Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure
24 hours
Dynamic mechanical power impact on NRS failure
Time Frame: 24 hours
Correlation between dynamic mechanical power within 24 hours from NRS start and NRS failure
24 hours
Correlation between nasal pressure (Pnose) and esophageal pressure
Time Frame: 24 hours
Correlation between nasal pressure (Pnose) and esophageal pressure
24 hours
Pnose impact on NRS failure
Time Frame: 24 hours
Correlation between Pnose within 24 hours from NRS start and NRS failure
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

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)

October 16, 2016

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UModenaReggio 266/16
  • 266/16 (Other Identifier: Local Ethics Committee of Modena (Italy))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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