Comparison of Esophageal Manometry and CT Scan Measurements

Study Overview
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Brief Summary
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The goal of this study is to determine the relationship between esophageal pressure (Pes) and superimposed pressure (SP) in subjects with morbid obesity.

Detailed Description
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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. During the research procedure, the Pes during the whole respiratory cycle, the CT image at the end-expiration, demographics, past and current medical history will be recorded. There will be no follow-up phase in this study.

Official Title
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Determination of Pleural Pressure in Subjects With Morbid Obesity

Conditions
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Morbid Obesity, Respiratory Failure

Intervention / Treatment
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* Radiation: low-dose chest CT scan
* Device: insertion of esophageal balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Morbid obese<br>BMI>40 kg/m2 | Radiation: low-dose chest CT scan<br>* The low-dose chest CT scan is now commonly used as a quick, painless, and non-invasive approach to screen for lung cancer. The radiation exposure from one low-dose CT scan of the chest (1.5 mSv) is comparable to 6 months of natural background radiation for a person living in the US.<br>Device: insertion of esophageal balloon<br>* The esophageal catheter is a flexible thin plastic tube with an air-filled balloon at the distal end. The tube will be placed through the nasopharynx after local anesthesia.<br>|
| Non-obese<br>BMI<30 kg/m2 | Radiation: low-dose chest CT scan<br>* The low-dose chest CT scan is now commonly used as a quick, painless, and non-invasive approach to screen for lung cancer. The radiation exposure from one low-dose CT scan of the chest (1.5 mSv) is comparable to 6 months of natural background radiation for a person living in the US.<br>Device: insertion of esophageal balloon<br>* The esophageal catheter is a flexible thin plastic tube with an air-filled balloon at the distal end. The tube will be placed through the nasopharynx after local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pressure measurement at a given superimposed pressure | 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal manometry, superimposed pressure, pleural pressure, chest CT scan