A Study of Body Fat Distribution and Airway Mechanics in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Body positioning.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers Only. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Imaging the Respiratory Effects of Truncal Adiposity in Healthy Subjects
Overview
This study investigates how body fat distribution affects airway closure and lung mechanics in healthy adults. Using Electrical Impedance Tomography (EIT), esophageal manometry, and computed tomography (CT), we aim to characterize how varying BMI and fat topography influence regional ventilation and airway collapse in supine and prone positions. Healthy volunteers with a range of BMIs will undergo a 2-hour imaging session with noninvasive and minimally invasive monitoring.
Detailed description
This physiological research study explores the relationship between body habitus, fat distribution, and mechanical responses of the lung to the prone and supine position. In a prospective, single-center, physiological, crossover study, study subjects (n=20) will be recruited among healthy volunteers across BMI categories. Lung function will be assessed in the supine and prone position (maintained for 15 min). Intrathoracic pressure (ITP) will be measured using esophageal manometry. Airway opening pressure (AOP) will be measured by as the airway pressure (non-invasively applied through a mask) needed to match ITP. Regional ventilation will be measured in both positions using electrical impedance tomography. Subjects will then transfer to the computed tomography (CT) scanner, where supine and prone images will be acquired during breath holds after normal expiration and after full inspiration. CT scans will then be analyzed for the quantification of lung volumes, thoracic adipose mass and airway geometry.
Interventions
- Procedure Body positioning
Each subject will breathe in both the supine and prone positions, randomly applied for 15 minutes each. The procedure will be performed twice: once for the assessment of respiratory physiology, and once for computed tomography acquisition.
Primary outcome measures
- Lung volumes [Time frame: Day 1, 15 minutes after breathing in the supine and in the prone position]
Secondary outcome measures (1)
- Thoracic adiposity [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Healthy subjects older than 18 years and younger than 80.
Exclusion criteria
- Pre-existing cardiopulmonary disease
- history of tobacco or ecigarette smoking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Spina S, Mantz L, Xin Y, Moscho DC, Ribeiro De Santis Santiago R, Grassi L, Nova A, Gerard SE, Bittner EA, Fintelmann FJ, Berra L, Cereda M. The pleural gradient does not reflect the superimposed pressure in patients with class III obesity. Crit Care. 2024 Sep 16;28(1):306. doi: 10.1186/s13054-024-05097-6. PMID 39285477
- Giani M, Restivo A, Raimondi Cominesi D, Fracchia R, Pozzi M, Del Sorbo L, Foti G, Brochard L, Rezoagli E. Prone-position decreases airway closure in a patient with ARDS undergoing venovenous extracorporeal membrane oxygenation. J Clin Monit Comput. 2024 Dec;38(6):1425-1429. doi: 10.1007/s10877-024-01182-x. Epub 2024 Jul 27. PMID 39066871
- Coudroy R, Vimpere D, Aissaoui N, Younan R, Bailleul C, Couteau-Chardon A, Lancelot A, Guerot E, Chen L, Brochard L, Diehl JL. Prevalence of Complete Airway Closure According to Body Mass Index in Acute Respiratory Distress Syndrome. Anesthesiology. 2020 Oct 1;133(4):867-878. doi: 10.1097/ALN.0000000000003444. PMID 32701573
- Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827. PMID 16963682
- Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016/j.chest.2021.01.055. Epub 2021 May 8. PMID 34099131
Identifiers
NCT: NCT07019831 · 2025P001553