NCT01806532Unknown不适用
Regional Lung Inflammation and Expansion in Mechanically Ventilated Patients - a PET/CT Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Regional 18F-FDG activity
研究概览
简要总结
The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated patients scheduled to undergo a CT scanning for their routine clinical care
- •More than 24 hours of mechanical ventilation
- •Less than 15 days of mechanical ventilation if patient presents ALI/ARDS (in order to exclude the late, fibrotic, stage of ARDS)
- •Mechanically ventilated patients with a diagnosis of sepsis
- •Less than 96 hours of mechanical ventilation
排除标准
- •Age less than 18 years
- •Hemodynamic instability, defined as: systolic blood pressure (SBP) < 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered "adequately stabilized" if the dose of the vasopressor/inotrope has not been stable for at least one hour
- •Hypoxemia, defined as: PaO2 < 70 mmHg on an inspired oxygen fraction (FiO2) greater than or equal to 0.9; FiO2 greater than or equal to 0.8 at baseline
- •Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when the patient is mobilized during routine nursing care such as repositioning/washing the patient or changing their bed linens
- •Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when a 15-25 second respiratory pause is introduced as per the study protocol. This will be tested by inducing such a pause prior to transporting the patient
- •Patients must be deemed by the treating clinical staff to be able to tolerate leaving the ICU for 90 minutes (40-60 minute imaging time + 30 minute safety margin). Treating MD, RT, and RN must all agree that the patient is stable for transport
- •Any acute or chronic condition which, in the opinion of the investigator, might confound the imaging measurements (such as, but not limited to, severe bronchospasm, pulmonary infection, and lung tumor)
- •"Air leaks" requiring tube thoracostomy (e.g., pneumothorax, bronchopleural fistula)
- •Pregnancy (since this is a study which would expose a fetus to radiation risk)
- •Patients who have neither an arterial nor a central venous line at the time of the enrollement
结局指标
主要结局
Regional 18F-FDG activity
时间窗: Day of imaging.
Each patient will undergo PET-CT scans and the regional 2-18F-fluoro-2-deoxy-D-glucose (18F-FDG) activity will be measured. This is a measure of regional neutrophil metabolic activity and is used to assess inflammation in the lung. The degree of inflammation will be related to the regional expansion of the lung, as measured by CT scan.
次要结局
未报告次要终点
研究者
Marcos Vidal Melo
Associate Professor, Harvard University
Massachusetts General Hospital
研究点 (1)
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