Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period

Larynx Clinical Trial

Official title:

Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636410
• Other study ID #: LARYNXUS
• Status: Recruiting
• Start date: June 14, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: November 2022
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: Lukasz Paprocki, M.D.
• Phone: 609205028
• Email: lukaszpaprocki1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

Inclusion Criteria:

• gestational age =32 weeks

Exclusion Criteria:

• gestational age < 32 weeks,

• presence of significant congenital anomalies,

• intubated neonate,

• unstable neonate.

Related Conditions & MeSH terms

• Laryngeal Diseases
• Larynx
• Trachea
• Tracheal Diseases

Intervention

Diagnostic Test:
• Larynx and trachea ultrasound
After meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation.

Locations

Country	Name	City	State
Poland	Department of Neonatology, Ujastek Medical Center	Krakow	Malopolskie
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Larynx and trachea anatomy description.	The aim of the study is the accurate description of the ultrasound anatomy of the larynx and trachea and establishment of reference ranges for the size of individual structures of the larynx and trachea in the neonatal population.	Through study completion, an average of 2 years
Primary	Ultrasound assessment of the mobility of the vocal cords	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.	Through study completion, an average of 2 years
Primary	Artificial intelligence algorithms based on artificial neural networks	The study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.	Through study completion, an average of 2 years