Preliminary Study of Pediatric Diaphragmatic Elastography

N/ANot Yet RecruitingNCT06666140

University Hospital, Strasbourg, France80 enrolled

Overview

This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group of patients without a history of hernia. The hypothesis is to be able to correlate the values found with the patients' symptomatology and thus to better monitor patients by a simple, accessible, painless and reproducible diagnostic tool, to better understand their evolution and even to be able to anticipate possible difficulties (reflux, respiratory disorders, scoliosis, etc.). Ultrasound elastography is a recent and clinically recognized method that uses an ultrasound approach to determine tissue stiffness in a non-invasive way.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Congenital Diaphragmatic Hernia

Interventions

The measurement of diaphragmatic stiffness by shear waves is performed with a high-frequency linear ultrasound probe, intercostally, during apneas lasting a few seconds. After quantitative diaphragm thickness measurements, the ultrasound probe positioning is unchanged and regions of interest are placed in the patient's diaphragm thickness as well as in the adjacent liver or spleen (baseline). A stiffness result is obtained in kPa. The elastography measurement extends the duration of the ultrasound scheduled as part of patient care by only 10 minutes. The examination is painless and non-invasive.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Group HDC: * Patient followed at the CCMR (centres de compétence maladies rares) HDC of the Strasbourg University Hospital * Aged between 3 and 17 years old inclusive * Indifferent Sex * Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme * Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent * Subject who has been informed of the results of the preliminary medical examination Control group: * Subject followed in pediatric surgery * Aged between 3 and 17 years old inclusive * Indifferent Sex * Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme * Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent * Subject who has been informed of the results of the preliminary medical examination Exclusion Criteria: * Group HDC: * Refusal * Language barrier * Diaphragmatic surgery within the last 3 months * Patient with a viral picture in progress at the time of examination (assessment by the investigator) * Patient treated with muscle relaxant * Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.) * Subject under safeguard of justice * Subject under guardianship or curatorship * Pregnant or breastfeeding woman Control group: * Patient without thoracic pathology * Refusal * Language barrier * Diaphragmatic pathology * Any myopathy * History of surgery of the upper digestive tract (esophagus and/or gastric and/or duodenal) * Patient on muscle relaxant * Patient with a viral picture in progress at the time of examination (assessment by the investigator) * Patient treated with muscle relaxant * Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.) * Subject under safeguard of justice * Subject under guardianship or curatorship * Pregnant or breastfeeding woman

Outcomes

Primary Outcomes

To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology.

Diaphragmatic rigidity in ultrasound elastographic analysis: measurement of diaphragm stiffness in shear wave elastography, in apnea (measurement in kPa).

Time frame: Baseline

Secondary Outcomes

To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis.

Bilateral measurements for each subject of the diaphragm performed in mode B, Intercostal analysis in mode B

Time frame: Baseline

To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis.

Bilateral measurements for each subject of the diaphragm made in elastography.

Time frame: Baseline

To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis.

Bilateral measurements for each subject of the diaphragm made in TM mode, Analysis in M mode (time-movement).

Time frame: Baseline

To evaluate the correlation between age and the different parameters measured by ultrasound (on the total population and then within the 3 groups: no hernia, hernia with plaque, hernia without plaque)

Collection of age and the various parameters measured by ultrasound (diaphragmatic thickness and rigidity).

Time frame: Baseline

To estimate the association between patient stiffness and symptomatology in HDC subjects.

Measurement of rigidity and collection of symptoms

Time frame: Baseline

Preliminary Study of Pediatric Diaphragmatic Elastography

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts