Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 3
- 主要终点
- Number of patients with recruitable lung
研究概览
简要总结
Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.
详细描述
In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure.
The goal of the study is the evaluation of the respiratory mechanics (peak inspiratory pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt) (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive for selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.
This study is multicentral observational trial in 3 University clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with COVID-19 and acute respiratory failure on invasive and noninvasive ventilation
排除标准
- •Patients who reached the following goals at conventional oxygen therapy (oxygen flow < 15 l/min): peripheral capillary oxygen saturation(SpO2) > 93%, no visible work of auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any catecholamines and/or life-threatening heart rhythm abnormalities),
- •less than 24 ours in intensive care unit (ICU) by any reason,
- •lung emphysema,
- •primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung diseases, etc) or tumour metastases in lungs,
- •chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
- •atonic coma.
结局指标
主要结局
Number of patients with recruitable lung
时间窗: On day 7 during mechanical ventilation
Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable
Optimum positive end-expiratory pressure (PEEP) level
时间窗: On day 7 during mechanical ventilation
Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
次要结局
- Change in alveolar dead space(On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation)
- Optimum positive end-expiratory pressure (PEEP) level(On day 3, 5, 10, 14, 21 during mechanical ventilation)
- Change in plethysmogram variability during recruitment maneuver(On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation)
- Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio(On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation)
- Change in driving pressure with different positive end-expiratory pressure (PEEP) levels(On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation)