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

May 7, 2019 updated by: Davide Chiumello, University of Milan

Validation of a New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure During Invasive Mechanical Ventilation in Patients With Acute Respiratory Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20142
        • Recruiting
        • ASST-Santi Paolo e Carlo, San Paolo Hospital
      • Milano, MI, Italy, 20142
        • Recruiting
        • Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to our Intensive Care Unit affected by acute respiratory failure, mechanically ventilated.

Description

Inclusion Criteria:

  • acute respiratory failure
  • invasive mechanical ventilation.

Exclusion Criteria:

  • haemodynamic instability
  • presence of barotrauma
  • esophageal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INNOVENT-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventilator-Induced Lung Injury

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe