Clinical and Functional Outcomes of Critically Ill Patients With COVID-19
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)
- Interventions
- Other: ARDSNet tableOther: Electrical Impedance TomographyOther: Driving Pressure
- Registration Number
- NCT05024500
- Lead Sponsor
- University of Pernambuco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases
- consent refusal by patient, family or doctor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADRSNet protocol ARDSNet table ARDSnet protocol is the current, standard of care for ARDS. Its used by setting PEEP and the fraction of inspired oxygen (FiO2) to achieve the oxygenation goal (SpO2 ≥ 93% - accepting the range of 90-96%) Electrical Impedance Tomography (EIT) Electrical Impedance Tomography After performing a modified alveolar recruitment maneuver, the PEEP decremental titration guided by the EIT will be set at the level above the intersection of the curves representing relative alveolar overdistention and collapse. Driving Pressure (DP) Driving Pressure setting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure.
- Primary Outcome Measures
Name Time Method Murray Score (LIS) 4 hours 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.
Potential lung recruitment measured during electrical impedance tomography 4 hours to quantify lung ventilation distribution
- Secondary Outcome Measures
Name Time Method diaphragmatic mobility measured during ultrasonography Through study completion, an average of 1 year diaphragmatic excursion expressed in millimeters
respiratory muscle strength Through study completion, an average of 1 year maximal static respiratory mouth pressures
Forced vital capacity (FVC) measured during spirometry Through study completion, an average of 1 year measures obtained by spirometry in outpatients
peripheral muscle strength I Through study completion, an average of 1 year 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.
six-minute walk test (6WT) Through study completion, an average of 1 year sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients
Length of days in intensive care unit (ICU days) Through study completion, an average of 1 year to quantify the number of days spent in a critical care unit
diaphragmatic thickening measured during ultrasonography Through study completion, an average of 1 year diaphragmatic thickening expressed in millimeters
Work of breathing (WOB) measured during surface electromyography 4 hours measured in root-mean-squared electromyography signals
Duration of mechanical ventilation (MV days) Through study completion, an average of 1 year to quantity the number of days with use of invasive mechanical ventilation in inpatients.
daily activities performance Through study completion, an average of 1 year to be evaluated by Barthel Index in outpatients
quality of life measured by Short Form Health survey 36 Through study completion, an average of 1 year score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
ICU Mortality Through study completion, an average of 1 year to quantify number of living days between ICU admission and deceased status
peripheral muscle strength II Through study completion, an average of 1 year to be evaluated by a handgrip dynamometers in outpatients
peripheral muscle strength III Through study completion, an average of 1 year to be evaluated by a handheld dynamometer in outpatients
functional capacity (Perme scale) Through study completion, an average of 1 year The minimum score is 0 and the maximum is 32. The higher the score, the better outcome.
breathing pattern measured during airway flowmeter Through study completion, an average of 1 year a device to quantify airway flow
Trial Locations
- Locations (4)
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
Hospital das Clinicas - UFPE
🇧🇷Recife, Pernambuco, Brazil