NCT03945409

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure
• Ventilator-Induced Lung Injury

Interventions

Type	Name	Description
DEVICE	OPTIVENT	OPTIVENT (SIDAM SRL, Mirandola, Italy) is a new fully automated and self-calibrating system that allows a real-time monitoring and recording of airway pressure and esophageal pressure during mechanical ventilation. The system required the insertion of an esophageal balloon catheter and an airway pressure transducer.

Timeline

• Start date: 2019-03-28
• Primary completion: 2020-03-01
• Completion: 2022-03-01
• First posted: 2019-05-10
• Last updated: 2019-05-10

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated device study