Pulmonary VentilationEVASTNCT06774118
Evaluation of Chest Wall Motion Symmetry During Ventilation in Healthy Subjects by Optoelectronic Plethysmography
An observational study of Pulmonary Ventilation, run by Université de Reims Champagne-Ardenne.
Trial summary
Pulmonary ventilation is the only macroscopically observable breathing step. The ventilatory mechanism has been extensively studied and knowledge of its operation is now well established. The thoraco-abdominal couple is generally considered as a homogeneous functional unit. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Pulmonary Ventilation
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2025
- 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 10 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: The study population will consist of consenting healthy subjects over 10 years of age, with no major surgical, traumatic or medical cardiopulmonary antecedents.
Who may be able to join
- aged between 10 and 70
- with no prior major cardiopulmonary surgical, traumatic or medical history
- agreeing to participate in the study
Who cannot join
- A major medical cardiopulmonary history, or a history of surgery or trauma to the thorax, abdomen or spine.
- A major medical cardiopulmonary history included any pathology requiring hospital treatment or allopathic therapy lasting more than 3 months.
- Active smoker
- Protected by law (guardianship, curatorship, safeguard of justice)
- Refusing to take part in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Barbe Coralie, Dr contact
About this study
Pulmonary ventilation is the only macroscopically observable breathing step. The ventilatory mechanism has been extensively studied and knowledge of its operation is now well established. The thoraco-abdominal couple is generally considered as a homogeneous functional unit. The anatomical organization of the trunk is not symmetrical. The right lung receives 55% of the volume of air mobilized, the heart is usually lateralized to the left and exerts a mechanical stress on the left lung, the thoracic diaphragm is asymmetrical. The densities of the subdiaphragmatic viscera vary greatly between hollow organs (stomach, colon) and full organs (liver rate).
Conventional spirometry, the gold-standard reference method in ventilatory analysis, allows to measure the quantities of air mobilized at inspiration and expiration. This quantitative method does not provide information on the kinematics of the different areas of the thorax and abdomen involved during breathing.
Read more
Optoelectronic plethysmography (OEP) is a non-invasive technique for the analysis of the 3D motion of passive markers placed on the surface of the subject's chest, abdomen and back. This technique, validated as a reliable alternative to conventional spirometry, allows the combination of quantitative measurements of respiratory volumes with qualitative measurements of thoraco-abdominal kinematics. The OEP has the specificity of allowing to choose a segmentation of the trunk to analyze the kinematics of the different identified zones. The most commonly used method in research is segmentation into three compartments (pulmonary thoracic, abdominal and abdominal thoracic).
The OEP studies also suggested the use of segmentation in relation to the median plane of the body to compare the symmetry of the three compartments described above. This 6-compartment segmentation was rarely used in respiratory analysis to assess interventions such as surgery of pulmonary rehabilitation protocols. To our knowledge, there is no study in healthy subjects to assess the level of symmetry of pulmonary ventilation. This type of study is a fundamental preliminary step to be able to subsequently study the symmetry of the ventilatory kinematics in the case of pathologies giving deformities of the thorax, spine and abdomen (scoliosis for example).
Read the detailed description
The main objective is to describe the degree of symmetry of the ventilatory kinematics in a healthy population using optoelectronic plethysmography to study thoracoabdominal-kinematics in a non-invasive manner by using a 3D optoelectronic motion analysis system in healthy subjects using a 6-compartment digital decomposition.
- Conditions
- Pulmonary Ventilation
- Being tested
- Data collection
- Keywords
- breathing symmetry, optoelectronic plethysmography, pulmonary ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Consenting healthy subjects with no previous major surgical, traumatic or medical cardiopulmonary history. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary ribcage asymmetry score
Opto-electronic plethysmography (OEP), using a 3D motion analysis system consisting of 8 optitrack FLEX 13 cameras and 93 passive markers placed on the thorax, abdomen and back of the subject, will assess the volume of all 6 compartments (pulmonary ribcage, abdominal ribcage and their subdivision into left and right parts).
pulmonary chest asymmetry score will be the difference between the volume of pulmonary ribcage right and the volume of pulmonary ribcage left
Measured: Day 0
Secondary outcomes (2)
abdominal ribcage asymmetry score
Opto-electronic plethysmography (OEP), using a 3D motion analysis system consisting of 8 optitrack FLEX 13 cameras and 93 passive markers placed on the thorax, abdomen and back of the subject, will assess the volume of all 6 compartments (pulmonary ribcage, abdominal ribcage and right and left abdomen).
abdominal chest asymmetry score will be the difference between the volume of abdominal ribcage right and the volume of abdominal ribcage left
Measured: Day 0
abdominal ribcage asymmetry score
Opto-electronic plethysmography (OEP), using a 3D motion analysis system consisting of 8 optitrack FLEX 13 cameras and 93 passive markers placed on the thorax, abdomen and back of the subject, will assess the volume of all 6 compartments (pulmonary ribcage, abdominal ribcage and right and left abdomen).
abdomen asymmetry score will be the difference between the volume of abdomen right and the volume of abdomen left
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary VentilationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774118
- Sponsor's protocol ID
- 2024_RIPH_21_EVAST
- Acronym
- EVAST
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chest Wall Motion Symmetry During Ventilation in Healthy Subjects by Optoelectronic Plethysmography
- ClinicalTrials.gov ID
- NCT06774118
- Acronym / sponsor ID
- EVAST / 2024_RIPH_21_EVAST
- Conditions
- Pulmonary Ventilation
- Keywords
- breathing symmetry, optoelectronic plethysmography, pulmonary ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 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.
Pulmonary ventilation is the only macroscopically observable breathing step. The ventilatory mechanism has been extensively studied and knowledge of its operation is now well established. The thoraco-abdominal couple is generally considered as a homogeneous functional unit. The anatomical organization of the trunk is not symmetrical. The right lung receives 55% of the volume of air mobilized, the heart is usually lateralized to the left and exerts a mechanical stress on the left lung, the thoracic diaphragm is asymmetrical. The densities of the subdiaphragmatic viscera vary greatly between hollow organs (stomach, colon) and full organs (liver rate).
Conventional spirometry, the gold-standard reference method in ventilatory analysis, allows to measure the quantities of air mobilized at inspiration and expiration. This quantitative method does not provide information on the kinematics of the different areas of the thorax and abdomen involved during breathing.
Optoelectronic plethysmography (OEP) is a non-invasive technique for the analysis of the 3D motion of passive markers placed on the surface of the subject's chest, abdomen and back. This technique, validated as a reliable alternative to conventional spirometry, allows the combination of quantitative measurements of respiratory volumes with qualitative measurements of thoraco-abdominal kinematics. The OEP has the specificity of allowing to choose a segmentation of the trunk to analyze the kinematics of the different identified zones. The most commonly used method in research is segmentation into three compartments (pulmonary thoracic, abdominal and abdominal thoracic).
The OEP studies also suggested the use of segmentation in relation to the median plane of the body to compare the symmetry of the three compartments described above. This 6-compartment segmentation was rarely used in respiratory analysis to assess interventions such as surgery of pulmonary rehabilitation protocols. To our knowledge, there is no study in healthy subjects to assess the level of symmetry of pulmonary ventilation. This type of study is a fundamental preliminary step to be able to subsequently study the symmetry of the ventilatory kinematics in the case of pathologies giving deformities of the thorax, spine and abdomen (scoliosis for example).
Detailed description
The main objective is to describe the degree of symmetry of the ventilatory kinematics in a healthy population using optoelectronic plethysmography to study thoracoabdominal-kinematics in a non-invasive manner by using a 3D optoelectronic motion analysis system in healthy subjects using a 6-compartment digital decomposition.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Other: Data collectionConsenting healthy subjects with no previous major surgical, traumatic or medical cardiopulmonary history. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of consenting healthy subjects over 10 years of age, with no major surgical, traumatic or medical cardiopulmonary antecedents.
Key inclusion criteria (3 listed)
- aged between 10 and 70
- with no prior major cardiopulmonary surgical, traumatic or medical history
- agreeing to participate in the study
Key exclusion criteria (5 listed)
- A major medical cardiopulmonary history, or a history of surgery or trauma to the thorax, abdomen or spine.
- A major medical cardiopulmonary history included any pathology requiring hospital treatment or allopathic therapy lasting more than 3 months.
- Active smoker
- Protected by law (guardianship, curatorship, safeguard of justice)
- Refusing to take part in the study
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 |
|---|---|---|
| Data collectionData collection | Other | healthy subjects |
Primary outcome
pulmonary ribcage asymmetry score
Time frame: Day 0
Opto-electronic plethysmography (OEP), using a 3D motion analysis system consisting of 8 optitrack FLEX 13 cameras and 93 passive markers placed on the thorax, abdomen and back of the subject, will assess the volume of all 6 compartments (pulmonary ribcage, abdominal ribcage and their subdivision into left and right parts). pulmonary chest asymmetry score will be the difference between the volume of pulmonary ribcage right and the volume of pulmonary ribcage left
2 secondary outcomes
abdominal ribcage asymmetry score
Time frame: Day 0
abdominal ribcage asymmetry score
Time frame: Day 0
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 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Ventilation
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
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.
Barbe Coralie, Dr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Ventilation, run by Université de Reims Champagne-Ardenne.
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 3 inclusion and 5 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 14 Jan 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 Gestonnairedu CURRS (0326918822 ext. +33, currs@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary ribcage asymmetry score (time frame: Day 0). 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 14 Jan 2025.