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

ConditionHealthy Volunteers Only

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorMaurizio F. Cereda, MD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Pre-existing cardiopulmonary disease

history of tobacco or ecigarette smoking

Trial design

Design model

Single group

Treatments tested in this trial

Body positioning
Procedure/Surgery
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Single arm, respiratory mechanics and adipose distribution in two body positionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Lung volumes

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

Time frame

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

Secondary outcomes

Thoracic adiposity

Thoracic adipose tissue will be quantified from analysis of computed tomography images as area of adipose tissue (cm\^2) at multiple vertebral levels.

Time frame

Day 1

Other outcomes

Airway diameters

CT scans will be digitally processed for the identification of airway branches down to the 4th bronchial generation. Bronchial cross sectional areas will then be measured (mm\^2) and compared between body positions.

Time frame

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

Intrathoracic pressure (ITP)

ITP (cmH2O) will be measured as the pressure in the esophagus at the end of expiration. This will be obtained through a thin balloon mounted catheter placed in the distal esophagus through a nostril.

Time frame

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

Airway opening pressure (AOP)

AOP (cmH2O) will be measured as the airway pressure that matches ITP during the graded application of positive airway pressure through a face mask.

Time frame

Day 1, after 15 minutes in supine and prone position

Regional ventilation

Changes in EIT-derived measurements of regional ventilation with PEEP titration and prone positioning. EIT regional ventilation is measured as percentage of total ventilation in each examined lung region.

Time frame

Day 1, after 15 minutes in the supine or prone position

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maurizio F. Cereda, MD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: