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

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945409
• Other study ID #: INNOVENT-2019
• Status: Recruiting
• Start date: March 28, 2019
• Est. completion date: March 2022

Study information

• Verified date: May 2019
• Source: University of Milan
• Contact: Davide Chiumello
• Phone: +390281844020
• Email: chiumello[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2022
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute respiratory failure

• invasive mechanical ventilation.

Exclusion Criteria:

• haemodynamic instability

• presence of barotrauma

• esophageal disease.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST-Santi Paolo e Carlo, San Paolo Hospital	Milan	MI
Italy	Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI. Review. — View Citation

Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. Review. — View Citation

Gattinoni L, Carlesso E, Cadringher P, Valenza F, Vagginelli F, Chiumello D. Physical and biological triggers of ventilator-induced lung injury and its prevention. Eur Respir J Suppl. 2003 Nov;47:15s-25s. Review. — View Citation

Mac Sweeney R, McAuley DF, Matthay MA. Acute lung failure. Semin Respir Crit Care Med. 2011 Oct;32(5):607-25. doi: 10.1055/s-0031-1287870. Epub 2011 Oct 11. Review. — View Citation

Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9. — View Citation

Tremblay L, Valenza F, Ribeiro SP, Li J, Slutsky AS. Injurious ventilatory strategies increase cytokines and c-fos m-RNA expression in an isolated rat lung model. J Clin Invest. 1997 Mar 1;99(5):944-52. — View Citation

Vincent JL, Akça S, De Mendonça A, Haji-Michael P, Sprung C, Moreno R, Antonelli M, Suter PM; SOFA Working Group. Sequntial organ failure assessment. The epidemiology of acute respiratory failure in critically ill patients(*). Chest. 2002 May;121(5):1602-9. — View Citation

Vincent JL, de Mendonça A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of transpulmonary pressure (cmH2O).	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.