Clinical trial NCT05636410: Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period
Official title: Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx
Trachea
Keywords: larynx
trachea
newborn
ultrasound
anatomy
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to recruit all consecutive infants borned at 32 and 42 weeks of gestation.

Brief summary: Diseases of the larynx and trachea are a heterogenous group of disorders. Witch may include congenital anatomical disorders, neoplastic changes, vocal cord paralysis of varied aetiology or narrowing of the larynx associated with long-term intubation. The multitude of disorders of these organs necessitates the continuing search for diagnostic methods which will not only provide answers to clinical questions but will also be safe and with the least level of interference with the wellbeing of the patient, which is of particular importance in the neonate.

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.

Detailed description: Diseases of the larynx and trachea are a heterogenous group of disorders. Witch may include congenital anatomical disorders, neoplastic changes, vocal cord paralysis of varied aetiology or narrowing of the larynx associated with long-term intubation. The multitude of disorders of these organs necessitates the continuing search for diagnostic methods which will not only provide answers to clinical questions but will also be safe and with the least level of interference with the wellbeing of the patient, which is of particular importance in the neonate.

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.

Eligibility criteria: Inclusion Criteria:

- gestational age ≥32 weeks

Exclusion Criteria:

* gestational age \< 32 weeks,
* presence of significant congenital anomalies,
* intubated neonate,
* unstable neonate.

Primary outcomes:
measure: Larynx and trachea anatomy description.
timeFrame: Through study completion, an average of 2 years
measure: Ultrasound assessment of the mobility of the vocal cords
timeFrame: Through study completion, an average of 2 years
measure: Artificial intelligence algorithms based on artificial neural networks
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Neonatology, Ujastek Medical Center
state: Malopolskie
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Study officials:
affiliation: Dr hab. n. med.
name: Renata Bokiniec, M. D
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.