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

ARDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02056977
• Other study ID #: 513.205
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2014
• Last updated: November 21, 2017
• Start date: February 2015
• Est. completion date: January 2018

Study information

• Verified date: November 2017
• Source: University of Sao Paulo General Hospital
• Contact: Marcelo BP Amato
• Phone: 3061-7361
• Email: marcelo.amato[@]limpneumo.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• Hypoxemic Respiratory Failure
• Post Operative Cardiac Surgery
• Respiratory Insufficiency

Intervention

Other:
• Titration
Individualized PEEP according to PEEP titration monitored by EIT
• control
PEEP selected according to a PaO2/FIO2 table as in the routines of the institution

Locations

Country	Name	City	State
Brazil	USP Instituto do Coração	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Financiadora de Estudos e Projetos

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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