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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03826797

Acronym

TEMPO

Enrollment

300

Registered

2019-02-01

Start date

2016-10-16

Completion date

2027-12-31

Last updated

2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Non invasive ventilation, Esophageal pressure, Transpulmonary pressure

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactAlessandro Marchioni, MD, PhD

marchioni.alessandro@unimore.it00390594225859

Outcome results