Preliminary Study of Pediatric Diaphragmatic Elastography
NCT ID: NCT06666140
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-11-15
2027-11-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group HDC
40 children with diaphragmatic hernia with or without prosthesis (HDC)
Ultrasonic elastography
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.
Control Group
40 children free of any diaphragmatic pathology
Ultrasonic elastography
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.
Interventions
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Ultrasonic elastography
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 Criteria
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Inclusion Criteria
* 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
* 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
3 Years
17 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Isabelle TALON, Professor
Role: PRINCIPAL_INVESTIGATOR
Locations
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Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Other Identifiers
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2024-A01627-40
Identifier Type: OTHER
Identifier Source: secondary_id
9420
Identifier Type: -
Identifier Source: org_study_id
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