- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06774118
Evaluation of Chest Wall Motion Symmetry During Ventilation in Healthy Subjects by Optoelectronic Plethysmography (EVAST)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gestonnairedu CURRS
- Phone Number: +33 0326918822
- Email: currs@univ-reims.fr
Study Contact Backup
- Name: Barbe Coralie, Dr
- Email: coralie.barbe1@univ-reims.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- aged between 10 and 70
- with no prior major cardiopulmonary surgical, traumatic or medical history
- agreeing to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy subjects
Consenting healthy subjects with no previous major surgical, traumatic or medical cardiopulmonary history.
|
Data collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
abdominal 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 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 |
Day 0
|
|
abdominal 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 right and left abdomen). abdomen asymmetry score will be the difference between the volume of abdomen right and the volume of abdomen left |
Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024_RIPH_21_EVAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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