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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
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.
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
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
Murray Score (LIS)
Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome.
Time frame: 4 hours
Potential lung recruitment measured during electrical impedance tomography
to quantify lung ventilation distribution
Time frame: 4 hours
Length of days in intensive care unit (ICU days)
to quantify the number of days spent in a critical care unit
Time frame: Through study completion, an average of 1 year
Work of breathing (WOB) measured during surface electromyography
measured in root-mean-squared electromyography signals
Time frame: 4 hours
Duration of mechanical ventilation (MV days)
to quantity the number of days with use of invasive mechanical ventilation in inpatients.
Time frame: Through study completion, an average of 1 year
ICU Mortality
to quantify number of living days between ICU admission and deceased status
Time frame: Through study completion, an average of 1 year
respiratory muscle strength
maximal static respiratory mouth pressures
Time frame: Through study completion, an average of 1 year
Forced vital capacity (FVC) measured during spirometry
measures obtained by spirometry in outpatients
Time frame: Through study completion, an average of 1 year
diaphragmatic mobility measured during ultrasonography
diaphragmatic excursion expressed in millimeters
Time frame: Through study completion, an average of 1 year
diaphragmatic thickening measured during ultrasonography
diaphragmatic thickening expressed in millimeters
Time frame: Through study completion, an average of 1 year
breathing pattern measured during airway flowmeter
a device to quantify airway flow
Time frame: Through study completion, an average of 1 year
peripheral muscle strength I
to be evaluated by Medical Research Council's scale. The minimum score is 0 and the maximum is 60. The higher the score, the better outcome.
Time frame: Through study completion, an average of 1 year
peripheral muscle strength II
to be evaluated by a handgrip dynamometers in outpatients
Time frame: Through study completion, an average of 1 year
peripheral muscle strength III
to be evaluated by a handheld dynamometer in outpatients
Time frame: Through study completion, an average of 1 year
six-minute walk test (6WT)
sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients
Time frame: Through study completion, an average of 1 year
functional capacity (Perme scale)
The minimum score is 0 and the maximum is 32. The higher the score, the better outcome.
Time frame: Through study completion, an average of 1 year
daily activities performance
to be evaluated by Barthel Index in outpatients
Time frame: Through study completion, an average of 1 year
quality of life measured by Short Form Health survey 36
score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Through study completion, an average of 1 year
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