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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03945409

Enrollment

Registered

2019-05-10

Start date

2019-03-28

Completion date

2022-03-31

Last updated

2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Ventilator-Induced Lung Injury

Keywords

ARDS, Respiratory Mechanics, Transpulmonary pressure, Pleural pressure

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.

Interventions

DEVICEOPTIVENT

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* acute respiratory failure * invasive mechanical ventilation.

Exclusion criteria

* haemodynamic instability * presence of barotrauma * esophageal disease.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactDavide Chiumello

chiumello@libero.it+390281844020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026