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

NCT07019831 | Not Yet Recruiting DMC

• 1 other identifier: 2025P001553
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers Only

Keywords

obesity; electrical impedance tomography; computed tomography; esophageal manometry; airway geometry

Outcome Measures

Primary Outcomes (1)

• Lung volumes

  Lung volumes will be measured from quantitative analysis of CT scans obtained in the supine and in the prone position.

  Day 1, 15 minutes after breathing in the supine and in the prone position

Secondary Outcomes (1)

• Thoracic adiposity

  Day 1

Other Outcomes (11)

• Airway diameters

  Day 1, after 15 minutes in the supine and prone positions

• Intrathoracic pressure (ITP)

  Day 1, after 15 minutes in the supine and prone positions.

• Airway opening pressure (AOP)

  Day 1, after 15 minutes in supine and prone position

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Body positioning

Interventions

Body positioning 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.

Also known as: Supine and prone

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects older than 18 years and younger than 80.

You may not qualify if:

• Pre-existing cardiopulmonary disease
• history of tobacco or ecigarette smoking

Sponsors & Collaborators

• Maurizio F. Cereda, MD: lead
• National Institutes of Health (NIH): collaborator

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Posture; Supine Position; Prone Position

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Maurizio Cereda, MD

CONTACT

16176430987; mcereda@mgh.harvard.edu

Lorenzo Berra, MD

CONTACT

617 724 0743; LBERRA@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Model Details: In a prospective, single-center, physiological, crossover study, the investigators will recruit 20 healthy volunteers across four standard body mass index categories (normal weight, overweight, class I obesity, class II/III obesity).

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share