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

Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pectus Excavatum; Pectus Carinatum
• Intervention / Treatment: Device: Vacuum Bell; Device: Dynamic Compression System

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud PATOIR, MD; Phone Number: +33 (0)477828847; Email: arnaud.patoir@chu-st-etienne.fr
• Study Contact Backup: Name: Arnauld GARCIN, CRA; Phone Number: +33 (0)477120286; Email: Arnauld.Garcin@chu-st-etienne.fr

Study Locations

• France
  • Saint-etienne, France, 42000
    • Recruiting
    • CHU de Saint-Etienne
    • Sub-Investigator: Jean-Claude BARTHELEMY, MD PhD
    • Sub-Investigator: Francois VARLET, MD PhD
    • Sub-Investigator: Olivier TIFFET, MD PhD
    • Sub-Investigator: Frederic COSTES, MD PhD
    • Principal Investigator: Arnaud PATOIR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pectus Excavatum; Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.	Device: Vacuum Bell; Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
Experimental: Pectus Carinatum; Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.	Device: Dynamic Compression System; Patients will be submitted to a dynamic compression system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low frequency (LF and LFnu)	It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.	One month after the end of treatment
LF/HF ratio	It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor.	One month after the end of treatment
Blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	One month after the end of treatment
Lung residual volume	It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing.	One month after the end of treatment
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.	One month after the end of treatment
Aerobic maximum power	It is measured by a stress test (incremental exercise)	One month after the end of treatment
Maximum heart rate	It is measured by a stress test (incremental exercise)	One month after the end of treatment
Left ventricular ejection fraction	It is measured by an echocardiography	One month after the end of treatment
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.	One month after the end of treatment
Nuss Questionnaire	It is a depression scale	One month after the end of treatment

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: MEDICALEX
• Investigators: Study Chair: Manuel LOPEZ, MD, CHU de Saint-Etienne; Principal Investigator: Arnaud PATOIR, MD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2015
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimated): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Pectus Excavatum; Pectus Carinatum; Vacuum Bell; Dynamic compression system; Hearth variability
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Cartilage Diseases; Funnel Chest; Pectus Carinatum
• Other Study ID Numbers: 1408081; 2014-A00841-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No