NCT06774118

Brief 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. 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

Keywords

breathing symmetryoptoelectronic plethysmographypulmonary ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0

Secondary Outcomes (2)

  • abdominal ribcage asymmetry score

    Day 0

  • abdominal ribcage asymmetry score

    Day 0

Study Arms (1)

healthy subjects

Consenting healthy subjects with no previous major surgical, traumatic or medical cardiopulmonary history.

Other: Data collection

Interventions

Data collection

healthy subjects

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • aged between 10 and 70
  • with no prior major cardiopulmonary surgical, traumatic or medical history
  • agreeing to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Gestonnairedu CURRS

CONTACT

Barbe Coralie, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

February 1, 2025

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01