Clinical trial NCT02528656: Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities
Official title: Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Pectus Carinatum
Keywords: Pectus Excavatum
Pectus Carinatum
Vacuum Bell
Dynamic compression system
Hearth variability
Autonomic Nervous System
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: MEDICALEX
First posted: 2015-08-19
Enrollment: 52
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: High frequency normalized index (HFnu)
timeFrame: One month after the end of treatment
Secondary outcomes:
measure: Low frequency (LF and LFnu)
timeFrame: One month after the end of treatment
measure: LF/HF ratio
timeFrame: One month after the end of treatment
measure: Blood pressure - Baroreflex
timeFrame: One month after the end of treatment
measure: Lung residual volume
timeFrame: One month after the end of treatment
measure: Maximum flow
timeFrame: One month after the end of treatment
measure: Aerobic maximum power
timeFrame: One month after the end of treatment
measure: Maximum heart rate
timeFrame: One month after the end of treatment
measure: Left ventricular ejection fraction
timeFrame: One month after the end of treatment
measure: Severity index of the anatomical damage
timeFrame: One month after the end of treatment
measure: Nuss Questionnaire
timeFrame: One month after the end of treatment
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Manuel LOPEZ, MD
role: STUDY_CHAIR
affiliation: CHU SAINT-ETIENNE
name: Arnaud PATOIR, MD
role: PRINCIPAL_INVESTIGATOR
References: