PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT02056977|
Recruitment Status : Recruiting
First Posted : February 6, 2014
Last Update Posted : November 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Cardiac Surgery ARDS Hypoxemic Respiratory Failure||Other: Titration Other: control||Not Applicable|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Individualized PEEP titration by EIT
Individualized PEEP according to PEEP titration monitored by EIT
Other Name: Individualized PEEP
Active Comparator: Control
PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio)
PEEP selected according to a PaO2/FIO2 table as in the routines of the institution
Other Name: Control PEEP
- To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver. [ Time Frame: 2 hours ]Evaluate the agreement between the ideal PEEP determined by the rapid PEEP titration maneuver versus the ideal PEEP determined by the slow PEEP titration maneuver. The degree of collapse and overdistention at each PEEP level, as estimated by EIT, will be also compared during both procedures. Ideal PEEP is the minimum PEEP capable of keeping collapse at < 5%.
- Stability of the selected PEEP according to the rapid titration in arterial oxygenation (SpO2, in %), respiratory system compliance (in cmH2O), and degree of collapse by EIT (in %) [ Time Frame: 4 hours ]Evaluate the stability of the selected PEEP (according to the rapid titration), by analyzing the maintenance of three variables over a four hour period: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT
- Comparison of the PEEP levels selected by the proposed strategy (rapid titration maneuver) and the PEEP levels used in the control group. [ Time Frame: 4 hours ]To compare the values of PEEP selected by both strategies, and to compare the evolution of the three variables (arterial oxygenation, respiratory system compliance, and degree of collapse by EIT) between propose strategy to control (default strategy currently used in the institution)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056977
|Contact: Marcelo BP Amatofirstname.lastname@example.org|
|Contact: Maria AM Nakamuraemail@example.com|
|USP Instituto do Coração||Recruiting|
|São Paulo, Brazil, 05.403-010|
|Contact: Marcelo BP Amato 30667361 firstname.lastname@example.org|
|Contact: Maria AM Nakamura 30667361 email@example.com|
|Sub-Investigator: Filomena Regina BG Galas|
|Principal Investigator:||Marcelo BP Amato||Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo|