Clinical trial NCT03945409: New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Ventilator-Induced Lung Injury
Keywords: ARDS
Respiratory Mechanics
Transpulmonary pressure
Pleural pressure
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to our Intensive Care Unit affected by acute respiratory failure, mechanically ventilated.

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.


Eligibility criteria: Inclusion Criteria:

* acute respiratory failure
* invasive mechanical ventilation.

Exclusion Criteria:

* haemodynamic instability
* presence of barotrauma
* esophageal disease.

Primary outcomes:
measure: Measure of transpulmonary pressure (cmH2O).
timeFrame: Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
state: MI
city: Milan
country: Italy
facility: ASST-Santi Paolo e Carlo, San Paolo Hospital
state: MI
Study officials:
References:
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.
citation: Vincent JL, de Mendonca 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. doi: 10.1097/00003246-199811000-00016.
citation: Vincent JL, Akca S, De Mendonca 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. doi: 10.1378/chest.121.5.1602.
citation: Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
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. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.
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. doi: 10.1183/09031936.03.00021303.
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. doi: 10.1172/JCI119259.
citation: Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin 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.