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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure

Clinicaltrials.gov identifier NCT03945409

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

Patients admitted to Intensive Care Unit often are affected by acute respiratory failure at admission or during hospital stay, with a mortality of 30%. Treatment remains largely supportive with mechanical ventilation as the mainstay of management by improving the hypoxemia and reducing the work of breathing; however, the mechanical forces generated during ventilation can further enhance pulmonary inflammation and edema, a process that has been termed ventilator induced lung injury (VILI). Consequently, in clinical practice the lung protective ventilation is mainly based on the reduction of the tidal volume, the airway and the transpulmonary plateau pressure. A good clinical practice is based on the assessment of changes in respiratory mechanics. Aim of the study is to determine the accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use in our Operative Unit.

  • Condition or Disease:Acute Respiratory Failure
    Ventilator-Induced Lung Injury
  • Intervention/Treatment: Device: OPTIVENT
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 40 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Validation of a New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure During Invasive Mechanical Ventilation in Patients With Acute Respiratory Failure
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: March 2022
Outcome Measures
  • Primary Outcome Measures: 1. Measure of transpulmonary pressure (cmH2O). [ Time Frame: Day 1. ]
    Validation of the new system in terms of accuracy and precision. The accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use, will be assessed by measure of airway and esophageal pressure at the end of an inspiratory and expiratory hold.
Eligibility Criteria
  • 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: Adult patients admitted to our Intensive Care Unit affected by acute respiratory failure, mechanically ventilated.
Criteria

Inclusion Criteria:

- acute respiratory failure

- invasive mechanical ventilation.

Exclusion Criteria:

- haemodynamic instability

- presence of barotrauma

- esophageal disease.

Contacts and Locations
Contacts

Contact: Davide Chiumello +390281844020 chiumello@libero.it

Locations

Italy, MI
ASST-Santi Paolo e Carlo, San Paolo Hospital
Milan

Italy, MI
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
Milano

Sponsors and Collaborators

University of Milan

More Information