Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

NCT ID: NCT02528656

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-12
• Study Completion Date: 2024-06-30

Brief Summary

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.

Conditions

Pectus Excavatum; Pectus Carinatum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pectus Excavatum

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

Group Type: EXPERIMENTAL

Vacuum Bell

Intervention Type: DEVICE

Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.

Pectus Carinatum

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

Group Type: EXPERIMENTAL

Dynamic Compression System

Intervention Type: DEVICE

Patients will be submitted to a dynamic compression system.

Interventions

Vacuum Bell

Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.

Intervention Type: DEVICE

Dynamic Compression System

Patients will be submitted to a dynamic compression system.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDICALEX

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel LOPEZ, MD

Role: STUDY_CHAIR

CHU de SAINT-ETIENNE

Arnaud PATOIR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Arnaud PATOIR, MD

Role: CONTACT

arnaud.patoir@chu-st-etienne.fr

(0)477828847 ext. +33

Arnauld GARCIN, CRA

Role: CONTACT

arnauld.garcin@chu-st-etienne.fr

(0)477120286 ext. +33

Other Identifiers

2014-A00841-46

Identifier Type: OTHER

Identifier Source: secondary_id

1408081

Identifier Type: -

Identifier Source: org_study_id