Healthy Volunteers OnlyNCT07019831
A Study of Body Fat Distribution and Airway Mechanics in Healthy Adults
A study testing Body positioning in people with Healthy Volunteers Only, run by Maurizio F. Cereda, MD.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- Body positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2028to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects older than 18 years and younger than 80.
Who cannot join
- Pre-existing cardiopulmonary disease
- history of tobacco or ecigarette smoking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Imaging the Respiratory Effects of Truncal Adiposity in Healthy Subjects
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.
Read the 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
- Being tested
- Body positioning
- Keywords
- obesity, electrical impedance tomography, computed tomography, esophageal manometry, airway geometry
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body positioningProcedure or surgery
Also called Supine and prone
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Body positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volumes
Lung volumes will be measured from quantitative analysis of CT scans obtained in the supine and in the prone position.
Measured: Day 1, 15 minutes after breathing in the supine and in the prone position
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maurizio F. Cereda, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Maurizio F. Cereda, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019831
- Sponsor's protocol ID
- 2025P001553
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39285477Giani 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.
PubMed 39066871Coudroy 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.
PubMed 32701573Jones 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.
PubMed 16963682Florio 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.
PubMed 34099131
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Respiratory Effects of Truncal Adiposity in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07019831
- Acronym / sponsor ID
- 2025P001553
- Conditions
- Healthy Volunteers Only
- Keywords
- obesity, electrical impedance tomography, computed tomography, esophageal manometry, airway geometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maurizio F. Cereda, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Single arm, respiratory mechanics and adipose distribution in two body positions | Experimental | Procedure: Body positioningA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects older than 18 years and younger than 80.
Key exclusion criteria (2 listed)
- Pre-existing cardiopulmonary disease
- history of tobacco or ecigarette smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body positioningAlso: Supine and proneEach 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. | Procedure or surgery | Single arm, respiratory mechanics and adipose distribution in two body positions |
Primary outcome
Lung volumes
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.
1 secondary outcome
Thoracic adiposity
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 39285477Spina 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.
- Background: PubMed 39066871Giani 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.
- Background: PubMed 32701573Coudroy 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.
- Background: PubMed 16963682Jones 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.
- Background: PubMed 34099131Florio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Body positioning in people with Healthy Volunteers Only, run by Maurizio F. Cereda, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Cereda, MD (16176430987, mcereda@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volumes (time frame: Day 1, 15 minutes after breathing in the supine and in the prone position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019831, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.