PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
Primary Purpose
Post Operative Cardiac Surgery, ARDS, Hypoxemic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Titration
control
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Cardiac Surgery focused on measuring Acute Respiratory Distress Syndrome, Cardiac Surgical Procedure, Mechanical Ventilation, Postoperative Complications, Positive End-Expiratory Pressure, Lung Collapse, Respiratory Failure, Electrical Impedance Tomography
Eligibility 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
Sites / Locations
- USP Instituto do CoraçãoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Titration
Control
Arm Description
Individualized PEEP titration by EIT
PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio)
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02056977
First Posted
February 5, 2014
Last Updated
November 21, 2017
Sponsor
University of Sao Paulo General Hospital
Collaborators
Financiadora de Estudos e Projetos
1. Study Identification
Unique Protocol Identification Number
NCT02056977
Brief Title
PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
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 Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Financiadora de Estudos e Projetos
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Cardiac Surgery, ARDS, Hypoxemic Respiratory Failure
Keywords
Acute Respiratory Distress Syndrome, Cardiac Surgical Procedure, Mechanical Ventilation, Postoperative Complications, Positive End-Expiratory Pressure, Lung Collapse, Respiratory Failure, Electrical Impedance Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Titration
Arm Type
Experimental
Arm Description
Individualized PEEP titration by EIT
Arm Title
Control
Arm Type
Active Comparator
Arm Description
PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio)
Intervention Type
Other
Intervention Name(s)
Titration
Other Intervention Name(s)
Individualized PEEP
Intervention Description
Individualized PEEP according to PEEP titration monitored by EIT
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
Control PEEP
Intervention Description
PEEP selected according to a PaO2/FIO2 table as in the routines of the institution
Primary Outcome Measure Information:
Title
To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver.
Description
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%.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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 %)
Description
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
Time Frame
4 hours
Other Pre-specified Outcome Measures:
Title
Comparison of the PEEP levels selected by the proposed strategy (rapid titration maneuver) and the PEEP levels used in the control group.
Description
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)
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo BP Amato
Phone
3061-7361
Email
marcelo.amato@limpneumo.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Maria AM Nakamura
Phone
3061-7361
Email
mamiyukinakamura@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo BP Amato
Organizational Affiliation
Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
USP Instituto do Coração
City
São Paulo
ZIP/Postal Code
05.403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo BP Amato
Phone
30667361
Email
marcelo.amato@limpneumo.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Maria AM Nakamura
Phone
30667361
Email
mamiyukinakamura@gmail.com
First Name & Middle Initial & Last Name & Degree
Filomena Regina BG Galas
12. IPD Sharing Statement
Citations:
PubMed Identifier
17667256
Citation
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.
Results Reference
background
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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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