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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
Sponsor:
Collaborator:
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Post Operative Cardiac Surgery ARDS Hypoxemic Respiratory Failure Other: Titration Other: control Not Applicable

Detailed 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 .


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Titration
Individualized PEEP titration by EIT
Other: Titration
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)
Other: control
PEEP selected according to a PaO2/FIO2 table as in the routines of the institution
Other Name: Control PEEP




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
  • Acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2) no >200 mmHg and bilateral pulmonary infiltrates on XRay consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary capillary wedge pressure <18 mmHg, when available).
  • Age > 18 and < 70 years old
  • Absence previous pulmonary disease
  • Left ventricular ejection fraction > 35%
  • Absence of previous cardiac surgery and / or lung disease;
  • Not requiring adjusted volume expansion (pulse pressure delta <13% or legs raising test without hemodynamic changes in cardiac index or mean arterial pressure).
  • Body mass index < 40 kg/m2
  • Written inform consent

Exclusion Criteria:

  • MAP < 70 mmHg
  • Noradrenaline > 1 micrograms/Kg/min
  • Acute arrhythmias
  • Blooding associated to hemodynamic instability
  • Need of re-surgery and/or mechanical circulatory assistance
  • Suspicion of neurological alteration
  • Chest tube with persistent air leak

Information from the National Library of Medicine

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


Contacts
Contact: Marcelo BP Amato 3061-7361 marcelo.amato@limpneumo.fm.usp.br
Contact: Maria AM Nakamura 3061-7361 mamiyukinakamura@gmail.com

Locations
Brazil
USP Instituto do Coração Recruiting
São Paulo, Brazil, 05.403-010
Contact: Marcelo BP Amato    30667361    marcelo.amato@limpneumo.fm.usp.br   
Contact: Maria AM Nakamura    30667361    mamiyukinakamura@gmail.com   
Sub-Investigator: Filomena Regina BG Galas         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Financiadora de Estudos e Projetos
Investigators
Principal Investigator: Marcelo BP Amato Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo

Publications:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02056977     History of Changes
Other Study ID Numbers: 513.205
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by University of Sao Paulo General Hospital:
Acute Respiratory Distress Syndrome
Cardiac Surgical Procedure
Mechanical Ventilation
Postoperative Complications
Positive End-Expiratory Pressure
Lung Collapse
Respiratory Failure
Electrical Impedance Tomography

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases