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| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
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The purpose of this study is to:
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titration | Experimental | Individualized PEEP titration by EIT |
|
| Control | Active Comparator | PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titration | Other | Individualized PEEP according to PEEP titration monitored by EIT |
|
| Measure | Description | Time Frame |
|---|---|---|
| To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver. | 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%. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 %) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the PEEP levels selected by the proposed strategy (rapid titration maneuver) and the PEEP levels used in the control group. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo BP Amato | Contact | 3061-7361 | marcelo.amato@limpneumo.fm.usp.br | |
| Maria AM Nakamura | Contact | 3061-7361 | mamiyukinakamura@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo BP Amato | Department of Cardio-Pulmonar, Pulmonary Division, Hospital das ClÃnicas, University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USP Instituto do Coração | Recruiting | São Paulo | 05.403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17667256 | Background | Costa EL, Amato M. Hemodynamic and respiratory changes during lung recruitment and descending optimal positive end-expiratory pressure titration with acute respiratory distress syndrome. Crit Care Med. 2007 Aug;35(8):1998-9; author reply 1999. doi: 10.1097/01.ccm.0000277060.87425.6b. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2018 | |
| Unrelease | Oct 9, 2018 | |
| Release | May 2, 2019 |
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| control | Other | PEEP selected according to a PaO2/FIO2 table as in the routines of the institution |
|
|
| 4 hours |
| 4 hours |
| Reset | Jul 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2018 | Oct 9, 2018 | |||
| May 2, 2019 | Jul 19, 2019 |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012128 | Respiratory Distress Syndrome |
| D011183 | Postoperative Complications |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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