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Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

NCT02528656 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-04-22

No results posted yet for this study

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

Interventions

DEVICE

Vacuum Bell

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

DEVICE

Dynamic Compression System

Patients will be submitted to a dynamic compression system.

Sponsors & Collaborators

  • MEDICALEX

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Manuel LOPEZ, MD · CHU de SAINT-ETIENNE

  • Arnaud PATOIR, MD · CHU SAINT-ETIENNE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528656 on ClinicalTrials.gov