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NCT03826797 Clinical Trial

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

Acute Respiratory Failure Clinical Trial

— TEMPO  

Official title:
Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03826797
Other study ID # UModenaReggio 266/16
Secondary ID 266/16
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2016
Est. completion date December 31, 2027

Study information
Verified date March 2023
Source University of Modena and Reggio Emilia
Contact Alessandro Marchioni, MD, PhD
Phone 00390594225859
Email marchioni.alessandro@unimore.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2027
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy University Hospital of Modena Policlinico 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 Esophageal pressure impact on non invasive respiratory support (NRS) failure Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure 24 hours
Secondary Transpulmonary pressure impact on NRS failure Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure 24 hours
Secondary Dynamic compliance impact on NRS failure Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure 24 hours
Secondary Dynamic mechanical power impact on NRS failure Correlation between dynamic mechanical power within 24 hours from NRS start and NRS failure 24 hours
Secondary Correlation between nasal pressure (Pnose) and esophageal pressure Correlation between nasal pressure (Pnose) and esophageal pressure 24 hours
Secondary Pnose impact on NRS failure Correlation between Pnose within 24 hours from NRS start and NRS failure 24 hours
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