Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period
NCT ID: NCT05636410
Last Updated: 2024-08-14
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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COMPLETED
300 participants
OBSERVATIONAL
2022-06-14
2023-07-31
Brief Summary
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In recent decades only a few studies have been reported which described the ultrasound anatomy of the larynx prior to and following intubation or that of the mobility of the vocal cords. To date, no standards have been published concerning the size of the structures of the larynx and trachea or the mobility of the vocal cords on ultrasound examination in the neonate. Additionally, there are no recommendations which include ultrasound examination as a reliable component of the diagnosis of congenital disorders of the larynx or other diseases of this organ.
Ultrasound is a non-invasive, repeatable and safe diagnostic method, which has recently, thanks the development of technology, provided for the very accurate imaging of even small structures, as well as their assessment on dynamic examination. Furthermore, the easy availability of this examination may in the future contribute to the early diagnosis of diseases of the larynx and trachea without the need to prolong neonatal hospitalization or anaesthesia.
In addition, the use of neural networks to analyse the ultrasound images obtained will provide for the development of algorithms which could become an irreplaceable tool, not only in the diagnosis of the disorders described, but also in predicating disorders affecting their further development or functional disorders in infancy.
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Detailed Description
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Diagnosis of diseases of the larynx and trachea in the neonate and infant is mainly based on endoscopy, magnetic resonance imaging and computer tomography. These investigations are invasive and not infrequently require anaesthetising the patient.
In recent decades only a few studies have been reported which described the ultrasound anatomy of the larynx prior to and following intubation or that of the mobility of the vocal cords. These studies involved small groups of subjects and were performed using lower quality ultrasound devices which did not provide for unequivocal conclusions to be drawn. To date, no standards have been published concerning the size of the structures of the larynx and trachea or the mobility of the vocal cords on ultrasound examination in the neonate. Additionally, there are no recommendations which include ultrasound examination as a reliable component of the diagnosis of congenital disorders of the larynx or other diseases of this organ.
Ultrasound is a non-invasive, repeatable and safe diagnostic method, which has recently, thanks the development of technology, provided for the very accurate imaging of even small structures, as well as their assessment on dynamic examination. Furthermore, the easy availability of this examination may in the future contribute to the early diagnosis of diseases of the larynx and trachea without the need to prolong neonatal hospitalization or anaesthesia.
In addition, the use of neural networks to analyse the ultrasound images obtained will provide for the development of algorithms which could become an irreplaceable tool, not only in the diagnosis of the disorders described, but also in predicating disorders affecting their further development or functional disorders in infancy.
The aim of the study is the accurate description of the ultrasound anatomy of the larynx and trachea and to establish reference ranges for the size of individual structures of the larynx and trachea in the neonatal population.
The study also aims to develop a universal method of ultrasound assessment of the mobility of the vocal cords on dynamic examination and to determine a rule for predicting the expected size of the laryngeal and tracheal structures in relation to anthropometric measurements.
Furthermore, the aim of the study is to promote the use of a non-invasive examination, such as ultrasonography, in the diagnosis of diseases of the larynx and trachea in the youngest patients.
Additionally, the study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Larynx and trachea ultrasound
After meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* presence of significant congenital anomalies,
* intubated neonate,
* unstable neonate.
0 Days
28 Days
ALL
No
Sponsors
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Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Principal Investigators
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Renata Bokiniec, M. D
Role: STUDY_CHAIR
Dr hab. n. med.
Locations
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Department of Neonatology, Ujastek Medical Center
Krakow, Lesser Poland Voivodeship, Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, , Poland
Countries
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References
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Ongkasuwan J, Ocampo E, Tran B. Laryngeal ultrasound and vocal fold movement in the pediatric cardiovascular intensive care unit. Laryngoscope. 2017 Jan;127(1):167-172. doi: 10.1002/lary.26051. Epub 2016 Apr 23.
Beale T, Twigg VM, Horta M, Morley S. High-Resolution Laryngeal US: Imaging Technique, Normal Anatomy, and Spectrum of Disease. Radiographics. 2020 May-Jun;40(3):775-790. doi: 10.1148/rg.2020190160.
Singh S, Jindal P, Ramakrishnan P, Raghuvanshi S. Prediction of endotracheal tube size in children by predicting subglottic diameter using ultrasonographic measurement versus traditional formulas. Saudi J Anaesth. 2019 Apr-Jun;13(2):93-99. doi: 10.4103/sja.SJA_390_18.
Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
Paprocki L, Migda B, Bokiniec R. Ultrasound assessment of larynx and trachea in the neonatal period-reference values. Eur Radiol. 2025 Jul 10. doi: 10.1007/s00330-025-11794-9. Online ahead of print.
Paprocki L, Migda B, Bokiniec R. Ultrasound Assessment of Larynx and Trachea in the Neonatal Period, Examination Standard with Predictive Values-Study Protocol. Diagnostics (Basel). 2023 Apr 28;13(9):1578. doi: 10.3390/diagnostics13091578.
Other Identifiers
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LARYNXUS
Identifier Type: -
Identifier Source: org_study_id
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