Comparison of Esophageal Manometry and CT Scan Measurements

NCT04213911 | Withdrawn

• 1 other identifier: CTobese2020
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Respiratory Failure

Keywords

esophageal manometry; superimposed pressure; pleural pressure; chest CT scan

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Morbid obese

BMI\>40 kg/m2

Radiation: low-dose chest CT scan; Device: insertion of esophageal balloon

Non-obese

BMI\<30 kg/m2

Radiation: low-dose chest CT scan; Device: insertion of esophageal balloon

Interventions

low-dose chest CT scan RADIATION

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.

Morbid obese; Non-obese

insertion of esophageal balloon DEVICE

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.

Morbid obese; Non-obese

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who are scheduled to take a chest CT scan for the clinical purpose at MGH Radiology Department
• adult subjects with BMI more than 40kg/m2
• adult subjects with BMI less than 30kg/m2
• More than 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (11)

• 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.

  PMID: 29323931 BACKGROUND

• 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.

  PMID: 24467647 BACKGROUND

• 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.

  PMID: 8111603 BACKGROUND

• Hibbert K, Rice M, Malhotra A. Obesity and ARDS. Chest. 2012 Sep;142(3):785-790. doi: 10.1378/chest.12-0117.

  PMID: 22948584 BACKGROUND

• 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.

  PMID: 28708679 BACKGROUND

• 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.

  PMID: 26584196 BACKGROUND

• 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.

  PMID: 7149443 BACKGROUND

• 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.

  PMID: 27063290 BACKGROUND

• 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.

  PMID: 21714641 BACKGROUND

• American College of Radiology and Radiological Society of North America. https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)