Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities (PECTUS)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Pectus Carinatum; Pectus Excavatum

Treatments: Device: Vacuum Bell; Device: Dynamic Compression System

Study type: Interventional

Funder types: Other

Identifiers

NCT02528656

1408081

2014-A00841-46 (Other Identifier)

Details and patient eligibility

About

The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated.

Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods.

Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography.

Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.

Enrollment: 52 estimated patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with pectus excavatum or pectus carinatum who does not require surgery
• Patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :For pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). For pectus excavatum less than 250 mbar depression.
• Signed informed consent
• Subject (or parents) affiliated to the French National Health Insurance

Exclusion criteria

• Skeletal disease, disturbing bone strength as osteogenesis imperfect and osteoporosis.
• Uncontrolled coagulopathies.
• Marfan syndrome, with mitral valve prolapse for pectus Excavatum.
• Atrial fibrillation
• Taking antiarrhythmic drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Pectus Excavatum

Experimental group

Description:

Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.

Treatment:

Device: Vacuum Bell

Pectus Carinatum

Experimental group

Description:

Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.

Treatment:

Device: Dynamic Compression System