NCT02528656

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

9.4 years

First QC Date

August 13, 2015

Last Update Submit

April 19, 2024

Conditions

Pectus ExcavatumPectus Carinatum

Keywords

Pectus ExcavatumPectus CarinatumVacuum BellDynamic compression systemHearth variabilityAutonomic Nervous System

Outcome Measures

Primary Outcomes (1)

  • High frequency normalized index (HFnu)

    It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor

    One month after the end of treatment

Secondary Outcomes (10)

  • Low frequency (LF and LFnu)

    One month after the end of treatment

  • LF/HF ratio

    One month after the end of treatment

  • Blood pressure - Baroreflex

    One month after the end of treatment

  • Lung residual volume

    One month after the end of treatment

  • Maximum flow

    One month after the end of treatment

  • +5 more secondary outcomes

Study Arms (2)

Pectus Excavatum

EXPERIMENTAL

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

Device: Vacuum Bell

Pectus Carinatum

EXPERIMENTAL

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

Device: Dynamic Compression System

Interventions

Vacuum BellDEVICE

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

Pectus Excavatum
Dynamic Compression SystemDEVICE

Patients will be submitted to a dynamic compression system.

Pectus Carinatum

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

RECRUITING

MeSH Terms

Conditions

Funnel ChestPectus Carinatum

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Manuel LOPEZ, MD

    CHU de SAINT-ETIENNE

    STUDY CHAIR

  • Arnaud PATOIR, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud PATOIR, MD

CONTACT

(0)477828847arnaud.patoir@chu-st-etienne.fr

Arnauld GARCIN, CRA

CONTACT

(0)477120286arnauld.garcin@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 19, 2015

Study Start

January 12, 2015

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)