Pulmonary DiseaseNCT05462600
Distribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring
An observational study of Pulmonary Disease and Respiratory System Abnormalities, run by University of California, San Diego at 1 site in United States.
Trial summary
Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Respiratory System Abnormalities, OSA
- What is being tested?
- Position change
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 30 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investigators will enroll 20 subjects with BMI 18.5-24.9 and 20 subjects with BMI 25 or more. The detailed inclusion criteria for subjects are listed below.
Who may be able to join
- 18 years or older
- Non-smokers
Who cannot join
- <18 years old
- Significant history of pulmonary disease
- Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
- Skin integrity issues precluding placement of nose clips, or transcutaneous carbon dioxide monitoring
- Inability to form a seal around a mouthpiece
- Known esophageal strictures, webs, or varices (if esophageal manometry to be included)
Show all 14Show fewer
- Known platelet count < 100,000 (if esophageal manometry to be included)
- On therapeutic anticoagulation (if esophageal manometry to be included)
- Known multidrug resistant (MDR) pulmonary infection
- Non-English language speakers
- Chronic hypoxemic respiratory failure
- Confirmed or suspected intracranial bleed, stroke, edema
- Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators or neurostimulators) or if device compatibility is in doubt
- Pregnant or lactating patients as safety and efficacy for use of EIT in such cases has not been verified
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego Health
La Jolla, California, 92037
About this study
Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. While effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. In pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. Obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (OSA). However, our understanding of these elements is limited even in the general population. The investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.
- Being tested
- Position change
- Medical subject headings
- Lung Diseases, Respiratory System Abnormalities, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position changeOther
Distribution of ventilation, respiratory drive, pulmonary mechanics and gas exchange will be measured in 3 unique positions: prone, head of bed (HOB) flat (i.e. 0 degrees) and HOB elevated (i.e. 30 degrees).
| Study group | Role | What they receive |
|---|---|---|
| BMI>24.9 kg/m2 | Not described Receives: Other: Position change | |
| BMI 18-24.9 kg/m2 | Not described Receives: Other: Position change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of ventilation
Change in regional ventilation distribution (ventral/dorsal) measured through electrical impedance tomography (EIT)
Measured: 3 hours
Respiratory drive
Respiratory drive differences will be measured by mean desaturation (change from baseline percent oxygen saturation) following breath-hold maneuvers
Measured: 3 hours
Respiratory drive
Respiratory drive differences will be assessed by the duration of maximal breath-hold (seconds)
Measured: 3 hours
Respiratory drive
Respiratory drive will also be assessed by measurement of occlusion pressure (cm H2O) at 100 ms (P0.1) after the initiation of an inspiratory effort against a closed circuit.
Measured: 3 hours
Secondary outcomes (3)
Pulmonary mechanics
Pulmonary mechanics will be measured by transpulmonary pressure (cmH2O)obtained from esophageal manometry (transpulmonary pressure= airway pressure- esophageal pressure)
Measured: 3 hours
Dead space fraction
Dead space fraction will be calculated by partial pressure arterial/transcutaneous CO2 (PCO2) minus partial pressure of CO2 in mixed expired gas divided by the partial pressure of arterial/transcutaneous CO2
Measured: 3 hours
Ventilatory ratio
Ventilatory ratio will be calculated as measured minute ventilation multiplied by the measured partial pressure of PCO2 divided (transcutaneous) by the predicted minute ventilation based on ideal body weight multiplied by the ideal PaCO2
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start19 Jul 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Pearce, University of California, San Diego
- Investigators
- Alex Pearce, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462600
- Sponsor's protocol ID
- 801980
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring
- ClinicalTrials.gov ID
- NCT05462600
- Acronym / sponsor ID
- 801980
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jul 2022 (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.
Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. While effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. In pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. Obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (OSA). However, our understanding of these elements is limited even in the general population. The investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI>24.9 kg/m2 | – | Other: Position change |
| BMI 18-24.9 kg/m2 | – | Other: Position change |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will enroll 20 subjects with BMI 18.5-24.9 and 20 subjects with BMI 25 or more. The detailed inclusion criteria for subjects are listed below.
Key inclusion criteria (2 listed)
- 18 years or older
- Non-smokers
Key exclusion criteria (14 listed)
- <18 years old
- Significant history of pulmonary disease
- Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
- Skin integrity issues precluding placement of nose clips, or transcutaneous carbon dioxide monitoring
- Inability to form a seal around a mouthpiece
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 |
|---|---|---|
| Position changeDistribution of ventilation, respiratory drive, pulmonary mechanics and gas exchange will be measured in 3 unique positions: prone, head of bed (HOB) flat (i.e. 0 degrees) and HOB elevated (i.e. 30 degrees). | Other | BMI 18-24.9 kg/m2, BMI>24.9 kg/m2 |
Primary outcome
Distribution of ventilation
Time frame: 3 hours
Change in regional ventilation distribution (ventral/dorsal) measured through electrical impedance tomography (EIT)
Respiratory drive
Time frame: 3 hours
Respiratory drive differences will be measured by mean desaturation (change from baseline percent oxygen saturation) following breath-hold maneuvers
Respiratory drive
Time frame: 3 hours
Respiratory drive differences will be assessed by the duration of maximal breath-hold (seconds)
Respiratory drive
Time frame: 3 hours
Respiratory drive will also be assessed by measurement of occlusion pressure (cm H2O) at 100 ms (P0.1) after the initiation of an inspiratory effort against a closed circuit.
3 secondary outcomes
Pulmonary mechanics
Time frame: 3 hours
Dead space fraction
Time frame: 3 hours
Ventilatory ratio
Time frame: 3 hours
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 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Alex Pearce principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Respiratory System Abnormalities, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of ventilation (time frame: 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.