Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

Pectus Excavatum Clinical Trial

— PECTUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02528656
• Other study ID #: 1408081
• Secondary ID: 2014-A00841-46
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2015
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Arnaud PATOIR, MD
• Phone: (0)477828847
• Email: arnaud.patoir[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Carinatum
• Pectus Excavatum

Intervention

Device:
• Vacuum Bell
Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
• Dynamic Compression System
Patients will be submitted to a dynamic compression system.

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	MEDICALEX

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	One month after the end of treatment
Secondary	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
Secondary	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
Secondary	Aerobic maximum power	It is measured by a stress test (incremental exercise)	One month after the end of treatment
Secondary	Maximum heart rate	It is measured by a stress test (incremental exercise)	One month after the end of treatment
Secondary	Left ventricular ejection fraction	It is measured by an echocardiography	One month after the end of treatment
Secondary	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
Secondary	Nuss Questionnaire	It is a depression scale	One month after the end of treatment