People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.
Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory
Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In
this scenario, lung protective strategies have been recommended for avoiding ventilator
induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP)
titration. However, the best method of PEEP titration for these patients remains unclear,
since its clinical and morphofunctional phenotype may differ from the conventional acute
respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition,
these patients' condition of long lasting MV dependency and bed restriction may lead to
deterioration of respiratory and peripheral muscles functions.
Objective: To compare the clinical and laboratory evolution and the respiratory and
peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to
PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and
electrical impedance tomography (EIT), as well as following them up after hospital discharge.
Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically
ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet
protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP
selected will be the closest level above the intercept point of cumulated collapse and
overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation,
respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and
functionality) will be monitored from intubation to extubation in the supine and prone
position. The outcomes of respiratory and peripheral muscles functionality will be monitored
for six months after hospital discharge. All ethical principles will be respected with either
written Free and Consent Term by the patient or relatives at the intensive care phase or at
the post ICU discharge phase. Data will be registered for posterior analysis, which considers
the difference between groups with p <0.05.
Expected results: Based on this study, it is expected to identify the Peep titration method
associated to the greater beneficial and less deleterious effects in critically ill patients
on MV. Also to address appropriate lung protective ventilation strategy for these patients
and to detect respiratory and peripheral muscle disorders as early as possible in critically
ill survivors.
Other: ARDSNet table
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
Other: Driving Pressure
The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
Other: Electrical Impedance Tomography
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
Inclusion Criteria:
- mechanically ventilated patients due to acute respiratory failure associated to
COVID-19 confirmed or suspected cases
Exclusion Criteria:
- consent refusal by patient, family or doctor
Hospital das Clinicas - UFPE
Recife, Pernambuco, Brazil
Physical Therapy Department, Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Hospital da Mulher do Recife
Recife, Pernambuco, Brazil
Hospital Geral Otavio de Freitas
Recife, Pernambuco, Brazil
Shirley Lima Campos, PhD, Study Director
Universidade Federal de Pernambuco