Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

Not Applicable

Recruiting

• Conditions: Pectus Excavatum; Pectus Carinatum
• Interventions: Device: Dynamic Compression System; Device: Vacuum Bell

• Registration Number: NCT02528656
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-12
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pectus Carinatum	Dynamic Compression System	Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.
Pectus Excavatum	Vacuum Bell	Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.

Primary Outcome Measures

Name	Time	Method
High frequency normalized index (HFnu)	One month after the end of treatment	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

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

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France