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

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

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.

Study Overview

• Status: Unknown
• Conditions: ARDS; Hypoxemic Respiratory Failure; Post Operative Cardiac Surgery
• Intervention / Treatment: Other: Titration; Other: control

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
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05.403-010
    • Recruiting
    • USP Instituto do Coração
    • Contact: Marcelo BP Amato; Phone Number: 30667361; Email: marcelo.amato@limpneumo.fm.usp.br
    • Contact: Maria AM Nakamura; Phone Number: 30667361; Email: mamiyukinakamura@gmail.com
    • Sub-Investigator: Filomena Regina BG Galas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Titration; Individualized PEEP titration by EIT	Other: Titration; Individualized PEEP according to PEEP titration monitored by EIT; Other Names: 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 Names: Control PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	4 hours

Other Outcome Measures

Outcome Measure	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)	4 hours

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Acute Respiratory Distress Syndrome; Postoperative Complications; Respiratory Failure; Electrical Impedance Tomography; Positive End-Expiratory Pressure; Cardiac Surgical Procedure; Lung Collapse
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 513.205