Clinical trial NCT04213911: Comparison of Esophageal Manometry and CT Scan Measurements
Official title: Determination of Pleural Pressure in Subjects With Morbid Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Respiratory Failure
Keywords: esophageal manometry
superimposed pressure
pleural pressure
chest CT scan
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are scheduled to take a chest CT scan without known lung disease. Morbid obesity will be defined as subjects with BMI \> 40 kg/m2 and non-obese will be defined as be subjects with BMI \< 30 kg/m2.

Brief summary: 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: 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:

1. 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%).
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.

Eligibility criteria: 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.

Primary outcomes:
measure: Esophageal pressure measurement at a given superimposed pressure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachussets General Hospital
state: Massachusetts
Study officials:
References:
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