search
Back to results

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

Primary Purpose

Pectus Excavatum, Pectus Carinatum

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vacuum Bell
Dynamic Compression System
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Excavatum focused on measuring Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System

Eligibility Criteria

10 Years - 30 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU de SAINT-ETIENNERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pectus Excavatum

Pectus Carinatum

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Low frequency (LF and LFnu)
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
LF/HF ratio
It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor.
Blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Lung residual volume
It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing.
Maximum flow
It is expressed in litres per minute and is measured during a pulmonary function testing. The patient is seated and his/her nose is blocked with a clamp. He/She must blow as fast and as hard as possible.
Aerobic maximum power
It is measured by a stress test (incremental exercise)
Maximum heart rate
It is measured by a stress test (incremental exercise)
Left ventricular ejection fraction
It is measured by an echocardiography
Severity index of the anatomical damage
It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine.
Nuss Questionnaire
It is a depression scale

Full Information

First Posted
August 13, 2015
Last Updated
October 19, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
MEDICALEX
search

1. Study Identification

Unique Protocol Identification Number
NCT02528656
Brief Title
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities
Acronym
PECTUS
Official Title
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
MEDICALEX

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Pectus Carinatum
Keywords
Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pectus Excavatum
Arm Type
Experimental
Arm Description
Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.
Arm Title
Pectus Carinatum
Arm Type
Experimental
Arm Description
Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.
Intervention Type
Device
Intervention Name(s)
Vacuum Bell
Intervention Description
Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
Intervention Type
Device
Intervention Name(s)
Dynamic Compression System
Intervention Description
Patients will be submitted to a dynamic compression system.
Primary Outcome Measure Information:
Title
High frequency normalized index (HFnu)
Description
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
Time Frame
One month after the end of treatment
Secondary Outcome Measure Information:
Title
Low frequency (LF and LFnu)
Description
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Time Frame
One month after the end of treatment
Title
LF/HF ratio
Description
It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor.
Time Frame
One month after the end of treatment
Title
Blood pressure - Baroreflex
Description
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Time Frame
One month after the end of treatment
Title
Lung residual volume
Description
It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing.
Time Frame
One month after the end of treatment
Title
Maximum flow
Description
It is expressed in litres per minute and is measured during a pulmonary function testing. The patient is seated and his/her nose is blocked with a clamp. He/She must blow as fast and as hard as possible.
Time Frame
One month after the end of treatment
Title
Aerobic maximum power
Description
It is measured by a stress test (incremental exercise)
Time Frame
One month after the end of treatment
Title
Maximum heart rate
Description
It is measured by a stress test (incremental exercise)
Time Frame
One month after the end of treatment
Title
Left ventricular ejection fraction
Description
It is measured by an echocardiography
Time Frame
One month after the end of treatment
Title
Severity index of the anatomical damage
Description
It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine.
Time Frame
One month after the end of treatment
Title
Nuss Questionnaire
Description
It is a depression scale
Time Frame
One month after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud PATOIR, MD
Phone
(0)477828847
Ext
+33
Email
arnaud.patoir@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Arnauld GARCIN, CRA
Phone
(0)477120286
Ext
+33
Email
arnauld.garcin@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel LOPEZ, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arnaud PATOIR, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois VARLET, MD PhD
First Name & Middle Initial & Last Name & Degree
Olivier TIFFET, MD PhD
First Name & Middle Initial & Last Name & Degree
Frederic COSTES, MD PhD
First Name & Middle Initial & Last Name & Degree
Jean-Claude BARTHELEMY, MD PhD
First Name & Middle Initial & Last Name & Degree
Arnaud PATOIR, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

We'll reach out to this number within 24 hrs