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

NCT ID: NCT02056977

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

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 .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Titration

Individualized PEEP titration by EIT

Group Type: EXPERIMENTAL

Titration

Intervention Type: OTHER

Individualized PEEP according to PEEP titration monitored by EIT

Control

PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio)

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

PEEP selected according to a PaO2/FIO2 table as in the routines of the institution

Interventions

Titration

Individualized PEEP according to PEEP titration monitored by EIT

Intervention Type: OTHER

control

PEEP selected according to a PaO2/FIO2 table as in the routines of the institution

Intervention Type: OTHER

Other Intervention Names

Individualized PEEP; Control PEEP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Financiadora de Estudos e Projetos

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo BP Amato

Role: PRINCIPAL_INVESTIGATOR

Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo

Locations

USP Instituto do Coração

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marcelo BP Amato

Role: CONTACT

Phone: 3061-7361

Email: marcelo.amato@limpneumo.fm.usp.br

Maria AM Nakamura

Role: CONTACT

Phone: 3061-7361

Email: mamiyukinakamura@gmail.com

Facility Contacts

Marcelo BP Amato

Role: primary

Maria AM Nakamura

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 17667256 (View on PubMed)

Other Identifiers

513.205

Identifier Type: -

Identifier Source: org_study_id