A Study of Body Fat Distribution and Airway Mechanics in Healthy Adults

NCT ID: NCT07019831

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-01-01
• Study Completion Date: 2030-06-30

Brief Summary

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.

Conditions

Healthy Volunteers Only

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm, respiratory mechanics and adipose distribution in two body positions

A total of 20 healthy volunteers will undergo assessments of respiratory mechanics in the supine and prone position. Then, the same subjects will undergo CT scans of the lungs in both positions. Body positions will be randomly applied for 15 minutes each.

Group Type: EXPERIMENTAL

Body positioning

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Supine and prone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Maurizio F. Cereda, MD

OTHER

Sponsor Role: lead

Responsible Party

Maurizio F. Cereda, MD

Associate Professor of Anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Maurizio Cereda, MD

Role: CONTACT

mcereda@mgh.harvard.edu

16176430987

Lorenzo Berra, MD

Role: CONTACT

LBERRA@mgh.harvard.edu

617 724 0743

References

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.

Reference Type: BACKGROUND

PMID: 39285477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39066871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32701573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16963682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34099131 (View on PubMed)

Other Identifiers

2025P001553

Identifier Type: -

Identifier Source: org_study_id