NCT Number: NCT07019831
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Supine and prone
Time frame: Day 1, 15 minutes after breathing in the supine and in the prone position
Lung volumes will be measured from quantitative analysis of CT scans obtained in the supine and in the prone position.
Time frame: Day 1
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, after 15 minutes in the supine and prone positions
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.
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 supine and prone position
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 the supine or prone position
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
Age will be measured in years and obtained during subject interview
Time frame: Day 1
Body height will be measured in meters and will be aggregated with body weight to yield body mass index (BMI) in kg/m^2.
Time frame: Day 1
Body weight will be measured in kg and will be aggregated with height to yield body mass index (BMI) in kg/m^2
Time frame: Day 1
Thoracic circumference will be measured in cm using a tape ruler placed at nipple level.
Time frame: Day 1
Abdominal circumference will be measured in cm using a tape ruler at the level of the umbilicus.
Time frame: Day 1
Hip circumference will be measured in cm using a tape ruler placed around the widest portion of the hips.
Time frame: Day 1
During subject interview, the presence of the following conditions will be recorded: hypertension, diabetes, asthma.
Contact information is provided by the study sponsor or research team.
Lorenzo Berra, MD
CONTACT
Maurizio Cereda, MD
CONTACT
Maurizio F. Cereda, MD
Other
Imaging the Respiratory Effects of Truncal Adiposity in Healthy Subjects
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