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Correlation Between Trans Esophageal Pressure and Non-invasive Mechanical Ventilation Failure in Patients With Acute Hypoxic Respiratory Failure (TEMPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826797
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Alessandro Marchioni, University of Modena and Reggio Emilia

Brief Summary:
This study aims at assessing the correlation between trans esophageal pressure and non-invasive mechanical ventilation failure in patients with acute hypoxic respiratory failure

Condition or disease
Respiratory Insufficiency

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Trans Esophageal Pressure and Non-invasive Mechanical Ventilation Failure in Patients With Acute Hypoxic Respiratory Failure
Actual Study Start Date : October 16, 2016
Actual Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Esophageal pressure impact on non invasive ventilation failure [ Time Frame: 48 hours ]
    Correlation between esophageal pressure values within 48 hours from NIV start and NIV failure


Secondary Outcome Measures :
  1. Transpulmonary pressure impact on non invasive ventilation failure [ Time Frame: 48 hours ]
    Correlation between transpulmonary pressure values within 48 hours from NIV start and NIV failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See inclusion criteria
Criteria

Inclusion Criteria:

  • Age >18 years
  • Acute hypoxic respiratory failure (P/F < 200)

Exclusion Criteria:

  • Acute pulmonary edema
  • ILD
  • Chest wall deformities
  • Immediate need for Mechanical Ventilation
  • Pregnancy
  • Hypercapnic RF

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826797


Contacts
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Contact: Alessandro Marchioni, MD, PhD 00390594225859 marchioni.alessandro@unimore.it

Locations
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Italy
University Hospital of Modena Policlinico Recruiting
Modena, Italy, 41125
Contact: Alessandro Marchioni, MD, PhD       marchioni.alessandro@unimore.it   
Sponsors and Collaborators
University of Modena and Reggio Emilia
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Responsible Party: Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03826797    
Other Study ID Numbers: UModenaReggio 266/16
266/16 ( Other Identifier: Local Ethics Committee of Modena (Italy) )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro Marchioni, University of Modena and Reggio Emilia:
Non invasive ventilation
Esophageal pressure
Transpulmonary pressure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases