Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure
TEMPO
2 other identifiers
observational
300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2016
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedMarch 23, 2023
March 1, 2023
7.4 years
January 28, 2019
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Transpulmonary pressure impact on NRS failure
24 hours
Dynamic compliance impact on NRS failure
24 hours
Dynamic mechanical power impact on NRS failure
24 hours
Correlation between nasal pressure (Pnose) and esophageal pressure
24 hours
Pnose impact on NRS failure
24 hours
Eligibility Criteria
See inclusion criteria
You may qualify if:
- Age \>18 years
- Acute hypoxic respiratory failure (P/F \< 200)
You may not qualify if:
- Acute pulmonary edema
- Chest wall deformities
- Immediate need for Mechanical Ventilation
- Pregnancy
- Hypercapnic RF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Modena Policlinico
Modena, 41125, Italy
Related Publications (2)
Tonelli R, Cortegiani A, Marchioni A, Fantini R, Tabbi L, Castaniere I, Biagioni E, Busani S, Nani C, Cerbone C, Vermi M, Gozzi F, Bruzzi G, Manicardi L, Pellegrino MR, Beghe B, Girardis M, Pelosi P, Gregoretti C, Ball L, Clini E. Nasal pressure swings as the measure of inspiratory effort in spontaneously breathing patients with de novo acute respiratory failure. Crit Care. 2022 Mar 24;26(1):70. doi: 10.1186/s13054-022-03938-w.
PMID: 35331323DERIVEDTonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
PMID: 32325004DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 1, 2019
Study Start
October 16, 2016
Primary Completion
February 28, 2024
Study Completion (Estimated)
December 31, 2027
Last Updated
March 23, 2023
Record last verified: 2023-03