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

M

Maurizio F. Cereda, MD

Status

Begins enrollment in a year or more

Conditions

Healthy Volunteers Only

Treatments

Procedure: Body positioning

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07019831
2025P001553

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Single arm, respiratory mechanics and adipose distribution in two body positions
Experimental group
Description:
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.
Treatment:
Procedure: Body positioning

Trial contacts and locations

0

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Central trial contact

Lorenzo Berra, MD; Maurizio Cereda, MD

Data sourced from clinicaltrials.gov

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