PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure

ARDS Clinical Trial

Official title: Comparison Between PEEP Levels Selected by Individualized PEEP Titration - Rapid Titration by EIT - and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure

Status Recruiting

Clinical Trial Summary

The purpose of this study is to:

• Compare PEEP level selected by individualized PEEP titration by electrical impedance tomography and PEEP level routinely used in post-operative cardiac patients with Hypoxemic Respiratory Failure;

• Evaluate the agreement between the results of a rapid titration (total procedure duration = 5 min) versus an already validated slow titration (total procedure duration = 40 min) of the same patient, sequentially. Specifically, degree of collapse and degree of distention in each PEEP level, estimated by EIT;

• Compare hemodynamics during the two maneuvers of PEEP titration;

• Evaluate the efficacy of the selected PEEP (minimum PEEP preventing lung collapse less than 5%) to maintain stable levels of the following variables: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT;

• Compare these results (evolution of the three variables, along 4 hours) with the control strategy (default strategy currently used in the institution) group.

Clinical Trial Description

The acute respiratory distress syndrome (ARDS) increases the morbidity and mortality of patients admitted to the intensive care unit (ICU). In the postoperative period of cardiac surgery, the use of intraoperative extracorporeal circulation is one of the factors triggering the syndrome, its incidence increasing.

Potentially, a protective ventilatory strategy with optimal positive end expiratory pressure (PEEP) could improve the prognosis of those patients with ARDS.

An already validated maneuver to titrate the ideal PEEP to these patients has a longer duration, about 40 minutes. The lung Electrical impedance tomography (EIT) monitors respiratory system mechanics and intrathoracic lung volume changes and provides information about regional behavior and recruitability of lung tissue and thereby allows shortening titration maneuver, reducing its hemodynamic effects.

Patients in the postoperative period of cardiac surgery with a diagnosis of Hypoxemic Respiratory Failure (PaO2/FiO2 < 250 mmHg, calculated at FiO2 60%, and the presence of bilateral infiltrates on chest radiography), admitted to the surgical ICU from Heart Institute, University of São Paulo.

Recruitment maneuver and PEEP titration maneuver will be monitored by EIT.

All patients will be followed and monitored for 4 hours, with measures of the evolution of alveolar collapse . Hemodynamic and oxygenation data will also be recorded . ;

Related Conditions & MeSH terms

• ARDS
• Hypoxemic Respiratory Failure
• Post Operative Cardiac Surgery
• Respiratory Insufficiency

• NCT number: NCT02056977
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Contact: Marcelo BP Amato
• Phone: 3061-7361
• Email: marcelo.amato@limpneumo.fm.usp.br
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Completion date: January 2018