Determination of Pleural Pressure in Subjects With Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Esophageal pressure measurement at a given superimposed pressure
研究概览
简要总结
The goal of this study is to determine the relationship between esophageal pressure (Pes) and superimposed pressure (SP) in subjects with morbid obesity.
详细描述
In the clinical setting, Pes is a surrogate for pleural pressure, while SP is measured by means of chest CT scan images. The SP highly approximates the vertical pleural pressure gradient both in normal lungs and injured lungs in lean subjects. It is known that in the healthy obese patient the Pes is higher than that in normal lean patients, but there is no information about the relationship between high Pes with the SP in subjects with morbid obesity.
The investigators hypothesized that factors other than superimposed pressure determine the high Pes in subjects with morbid obesity. Hence, Pes should be high despite the low SP found in healthy obese individuals.
The investigators will test this hypothesis in a prospective observational cohort study.
In 12 subjects (6 with body mass index > 40kg/m2, and 6 with body mass index < 30kg/m2 ) with scheduled chest CT scan for clinical purposes:
- The Pes will be measured during spontaneous breathing (baseline values at end-expiration and variations during tidal breathing). To achieve this purpose, an esophageal balloon (AVEATM Ventilator Esophageal Pressure Monitoring Tube Set, 8 FR, CareFusion, Yorba Linda, CA, USA) will be inserted after administration of local anesthesia (lidocaine spray 2%).
- The SP will be determined by lung computed tomography imaging and the pleural pressure will be calculated in non-dependent lung regions as the difference between Pes and SP. For this purpose, an additional low-dose CT scan at the end-expiration will be taken after the scheduled CT scan.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are scheduled to take a chest CT scan for the clinical purpose at MGH Radiology Department
- •6 adult subjects with BMI more than 40kg/m2
- •6 adult subjects with BMI less than 30kg/m2
- •More than 18 years old
排除标准
- •Presence of pneumothorax
- •History of spontaneous pneumothorax
- •Severe coagulopathy (INR ≥ 4)
- •Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
- •Usage of any devices with electric current generation such as pacemakers or internal cardiac defibrillator
- •Recent esophageal trauma or surgery
- •Other esophageal diseases, such as esophageal cancer, leak, varices, and hernia
- •Presence of hypoxemia, short of breath and dysphagia.
- •Presence or suspicion of pneumonia or lung fibrosis.
结局指标
主要结局
Esophageal pressure measurement at a given superimposed pressure
时间窗: through study completion, an average of 1 year
The esophageal pressure will be determined via esophageal balloon at the end of exhalation. The superimposed pressure will be calculated by chest CT scan image at the end of exhalation.
次要结局
未报告次要终点
研究者
Lorenzo Berra, MD
Medical doctor
Massachusetts General Hospital