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NCT Number: NCT03826797

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

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).

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Modena Policlinico

Modena, 41125, Italy

Location status: Recruiting

Location contact

Alessandro Marchioni, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Transpulmonary pressure impact on NRS failure

    Time frame: 24 hours

    Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure

  2. Dynamic compliance impact on NRS failure

    Time frame: 24 hours

    Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure

  3. 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

  4. Correlation between nasal pressure (Pnose) and esophageal pressure

    Time frame: 24 hours

    Correlation between nasal pressure (Pnose) and esophageal pressure

  5. Pnose impact on NRS failure

    Time frame: 24 hours

    Correlation between Pnose within 24 hours from NRS start and NRS failure

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Marchioni, MD, PhD

CONTACT

[email protected]

00390594225859

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: TEMPO

Important dates

Study start
2016
Primary completion
2024
Study completion
2027
First posted
Feb 1, 2019
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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