Laryngeal DiseasesECHO-LARYNXNCT06559293
Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX
An observational study of Laryngeal Diseases and Ultrasound, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Laryngeal Diseases, Ultrasound
- What is being tested?
- laryngeal ultrasound
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- Child
Study population: Patients treated in the pediatric ENT department at Bordeaux University Hospital, whether in consultation hospitalization.
Who may be able to join
- patients treated in the pediatric ENT unit at Bordeaux University Hospital, aged between 0 and 15 years
Who cannot join
- intubated patient,
- haemodynamic
- respiratory instability
- opposition to participation expressed by parents or patient
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico-faciale et d'ORL pédiatrique
Bordeaux, 33076
Thomas SAGARDOY, MD
About this study
Official title: Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population
Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. The aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.
Read the detailed description
According to current knowledge, the gold standard for diagnosing laryngeal pathologies is flexible fiberoptic laryngoscopy (FFL), as it allows visualisation of the motricity of the laryngeal structures and the appearance of the mucous membranes. However, this is an invasive examination, which can be poorly tolerated in the pediatric population. This poor tolerance can make it difficult to obtain an accurate diagnosis because of the child's movements. With the aim of improving patient comfort without compromising diagnostic performance, some studies describe laryngeal ultrasound (LUS) as an alternative to FFL. This imaging examination appears to be better tolerated than FFL because it is less invasive for the patient. However, there are few data available in the infant population. The main limitations of LUS are obtaining a satisfactory ultrasound window and inter-rater reproducibility. For these reasons, the aim of this study is to assess the feasibility of LUS in the pediatric population and to obtain reference frame enabling the different laryngeal structures to be visualised. We will include around one hundred patients treated in the pediatric ENT unit, with or without laryngeal pathology. An ultrasound record will be performed during the consultation in addition to the usual examination. The record will be analysed by a blinded assessor. A single consultation will be required and no follow-up is planned.
- Conditions
- Laryngeal Diseases, Ultrasound
- Being tested
- laryngeal ultrasound
- Keywords
- transcutaneous laryngeal ultrasound, pediatric population, otorhinolaryngology, ENT
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal ultrasoundDiagnostic test
laryngeal ultrasound with linear probe will be positioned on the patient's neck. A list of anatomical sites to be visualised will be determined beforehand. Once all the pre-determined structures have been visualised, in an axial and sagittal plane, we will note the position of the ultrasound probe and its orientation. This will enable us to determine the ideal position of the ultrasound probe for obtaining all the elements of interest on a section that will be called the reference section.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducible ultrasound images
Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx
Measured: At Baseline (D0)
Secondary outcomes (1)
Demographic characteristics
We will evaluate the demographic characteristics that may affect the reproducibility of ultrasound images
Measured: At Baseline (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas SAGARDOY, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559293
- Sponsor's protocol ID
- CHUBX 2023/86
- Acronym
- ECHO-LARYNX
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population
- ClinicalTrials.gov ID
- NCT06559293
- Acronym / sponsor ID
- ECHO-LARYNX / CHUBX 2023/86
- Conditions
- Laryngeal Diseases, Ultrasound
- Keywords
- transcutaneous laryngeal ultrasound, pediatric population, otorhinolaryngology, ENT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. The aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.
Detailed description
According to current knowledge, the gold standard for diagnosing laryngeal pathologies is flexible fiberoptic laryngoscopy (FFL), as it allows visualisation of the motricity of the laryngeal structures and the appearance of the mucous membranes. However, this is an invasive examination, which can be poorly tolerated in the pediatric population. This poor tolerance can make it difficult to obtain an accurate diagnosis because of the child's movements. With the aim of improving patient comfort without compromising diagnostic performance, some studies describe laryngeal ultrasound (LUS) as an alternative to FFL. This imaging examination appears to be better tolerated than FFL because it is less invasive for the patient. However, there are few data available in the infant population. The main limitations of LUS are obtaining a satisfactory ultrasound window and inter-rater reproducibility. For these reasons, the aim of this study is to assess the feasibility of LUS in the pediatric population and to obtain reference frame enabling the different laryngeal structures to be visualised. We will include around one hundred patients treated in the pediatric ENT unit, with or without laryngeal pathology. An ultrasound record will be performed during the consultation in addition to the usual examination. The record will be analysed by a blinded assessor. A single consultation will be required and no follow-up is planned.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients treated in the pediatric ENT department at Bordeaux University Hospital, whether in consultation hospitalization.
Key inclusion criteria (1 listed)
- patients treated in the pediatric ENT unit at Bordeaux University Hospital, aged between 0 and 15 years
Key exclusion criteria (4 listed)
- intubated patient,
- haemodynamic
- respiratory instability
- opposition to participation expressed by parents or patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laryngeal ultrasoundlaryngeal ultrasound with linear probe will be positioned on the patient's neck. A list of anatomical sites to be visualised will be determined beforehand. Once all the pre-determined structures have been visualised, in an axial and sagittal plane, we will note the position of the ultrasound probe and its orientation. This will enable us to determine the ideal position of the ultrasound probe for obtaining all the elements of interest on a section that will be called the reference section. | Diagnostic test | – |
Primary outcome
Reproducible ultrasound images
Time frame: At Baseline (D0)
Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx
1 secondary outcome
Demographic characteristics
Time frame: At Baseline (D0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas SAGARDOY, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Diseases and Ultrasound, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas SAGARDOY, MD (05.57.82.19.01, thomas.sagardoy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducible ultrasound images (time frame: At Baseline (D0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.