Clinical, Respiratory, Peripheral, Muscle and Functionality Outcomes of Adult ICU Inpatients and Rehabilitation-center Outpatients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Murray Score (LIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
trial participants, data collectors and outcome assessors or committees will remain blinded to the patient assigned group of treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases
排除标准
- •consent refusal by patient, family or doctor
结局指标
主要结局
Murray Score (LIS)
时间窗: 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
时间窗: 4 hours
to quantify lung ventilation distribution
次要结局
- diaphragmatic mobility measured during ultrasonography(Through study completion, an average of 1 year)
- respiratory muscle strength(Through study completion, an average of 1 year)
- Forced vital capacity (FVC) measured during spirometry(Through study completion, an average of 1 year)
- peripheral muscle strength I(Through study completion, an average of 1 year)
- six-minute walk test (6WT)(Through study completion, an average of 1 year)
- Length of days in intensive care unit (ICU days)(Through study completion, an average of 1 year)
- diaphragmatic thickening measured during ultrasonography(Through study completion, an average of 1 year)
- daily activities performance(Through study completion, an average of 1 year)
- quality of life measured by Short Form Health survey 36(Through study completion, an average of 1 year)
- Work of breathing (WOB) measured during surface electromyography(4 hours)
- Duration of mechanical ventilation (MV days)(Through study completion, an average of 1 year)
- ICU Mortality(Through study completion, an average of 1 year)
- peripheral muscle strength II(Through study completion, an average of 1 year)
- peripheral muscle strength III(Through study completion, an average of 1 year)
- functional capacity (Perme scale)(Through study completion, an average of 1 year)
- breathing pattern measured during airway flowmeter(Through study completion, an average of 1 year)
研究者
Shirley Lima Campos
Associate Professor
Universidade Federal de Pernambuco