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

• Conditions: Acute Respiratory Failure; Ventilator-Induced Lung Injury

• Registration Number: NCT03945409
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2019-04-17
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-07
• Last Update Submitted: 2019-05-07
• Study First Posted: 2019-05-10
• Last Update Posted: 2019-05-10
• Primary Completion: 2020-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• acute respiratory failure
• invasive mechanical ventilation.

Exclusion Criteria

• haemodynamic instability
• presence of barotrauma
• esophageal disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of transpulmonary pressure (cmH2O).	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.

Trial Locations

Locations (2)

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

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