Comparison of Esophageal Manometry and CT Scan Measurements
NCT ID: NCT04213911
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-03-31
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Morbid obese
BMI\>40 kg/m2
low-dose chest CT scan
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.
insertion of esophageal balloon
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.
Non-obese
BMI\<30 kg/m2
low-dose chest CT scan
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.
insertion of esophageal balloon
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.
Interventions
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low-dose chest CT scan
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.
insertion of esophageal balloon
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Lorenzo Berra, MD
Medical doctor
Locations
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Massachussets General Hospital
Boston, Massachusetts, United States
Countries
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References
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American College of Radiology and Radiological Society of North America. https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray.
National Cancer Institute at the National Institutes of Health. Computed Tomography (CT): Questions and Answers. [July 20, 2012]; Available from: http:://www.cancer.gov/cancertopics/factsheet/detection/CT.
Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC.
Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
Pelosi P, D'Andrea L, Vitale G, Pesenti A, Gattinoni L. Vertical gradient of regional lung inflation in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994 Jan;149(1):8-13. doi: 10.1164/ajrccm.149.1.8111603.
Hibbert K, Rice M, Malhotra A. Obesity and ARDS. Chest. 2012 Sep;142(3):785-790. doi: 10.1378/chest.12-0117.
Fumagalli J, Berra L, Zhang C, Pirrone M, Santiago RRS, Gomes S, Magni F, Dos Santos GAB, Bennett D, Torsani V, Fisher D, Morais C, Amato MBP, Kacmarek RM. Transpulmonary Pressure Describes Lung Morphology During Decremental Positive End-Expiratory Pressure Trials in Obesity. Crit Care Med. 2017 Aug;45(8):1374-1381. doi: 10.1097/CCM.0000000000002460.
Pirrone M, Fisher D, Chipman D, Imber DA, Corona J, Mietto C, Kacmarek RM, Berra L. Recruitment Maneuvers and Positive End-Expiratory Pressure Titration in Morbidly Obese ICU Patients. Crit Care Med. 2016 Feb;44(2):300-7. doi: 10.1097/CCM.0000000000001387.
Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Other Identifiers
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CTobese2020
Identifier Type: -
Identifier Source: org_study_id
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