Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The distribution of ventilation
研究概览
简要总结
Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.
详细描述
The multi-center prospective observational study will enroll 20 adult ARDS patients under mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be waived due to the nature of observational study. Patients with positive SARS-CoV-2 infection will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The distribution of ventilation will be evaluated with EIT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with positive SARS-CoV-2 infection＊
- •Patients with ARDS under mechanical ventilation＊＊
- •Patients ≧ 18 years old
- •Definition of SARS-CoV-2 infection positive: SARS-CoV-2 infection is defined as being positive in RT-PCR (real time reverse transcriptase-polymerase chain reaction) assay using nasal or pharyngeal swab samples.
- •Definition of ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 300 mmHg with PEEP ≧ 5 cmH2O)
排除标准
- •Contraindication for EIT monitoring
- •Unstable spine or pelvic fractures
- •Pacemaker, automatic implantable cardioverter defibrillator
- •Skin lesions between the 4th and 5th ribs where the EIT belt is worn
- •Home mechanical ventilation before inclusion
- •DNR (do-not-resuscitate)
- •Increased intracranial pressure (> 18 mmHg)
结局指标
主要结局
The distribution of ventilation
时间窗: Through study completion (up to 24 hours)
The distribution of ventilation measured by EIT at PEEP 5 and 15.
次要结局
- Silent spaces(Through study completion (up to 24 hours))
- Respiratory system compliance(Through study completion (up to 24 hours))
- Oxygenation(Through study completion (up to 24 hours))
- Dead space ventilation ratio(Through study completion (up to 24 hours))