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

Study acronym: TEMPO
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated March 23, 2023 (before its estimated February 28, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 100 to 300
    • Primary completion date: Feb 28, 2022 to Feb 28, 2024
    v9
  2. Primary endpoint revised
    • Secondary endpoints: 4 to 5
    • Study title revised
    v8
  3. Study completion date: Dec 31, 2022 to Dec 31, 2027v7
  4. Eligibility criteria shortened, about 1 wordv6
  5. Primary completion date: Feb 28, 2021 to Feb 28, 2022
    • Enrollment target: 70 to 100
    • Secondary endpoints: 3 to 4
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Enrollment target: 30 to 70
    • Primary completion date: Oct 31, 2019 to Feb 28, 2021
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Secondary endpoints: 1 to 3
    v4
  2. Start date: Oct 1, 2016 to Oct 16, 2016v3
  3. Primary completion date changed from estimate of Dec 31, 2020 to Oct 31, 2019
    • Start date: Jan 29, 2019 to Oct 1, 2016
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03826797
Lead Sponsor University of Modena and Reggio Emilia
Conditions
(from sponsor)		 Acute Respiratory Failure
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov