Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period

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.

Study Overview

• Status: Recruiting
• Conditions: Larynx; Trachea
• Intervention / Treatment: Diagnostic test: Larynx and trachea ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lukasz Paprocki, M.D.; Phone Number: +48 609205028; Email: lukaszpaprocki1@gmail.com
• Study Contact Backup: Name: Renata Bokiniec, M.D.; Phone Number: +48 225966155; Email: rbokiniec@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland, 00-315
    • Recruiting
    • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
    • Contact: Renata Bokiniec, M.D.; Phone Number: +48 225966155; Email: neonatologia@szpitalkarowa.pl
    • Principal Investigator: Lukasz Paprocki, M. D.
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-752
      • Not yet recruiting
      • Department of Neonatology, Ujastek Medical Center
      • Contact: Łukasz Paprocki, MD; Phone Number: +48 609105028; Email: lukaszpaprocki1@gmail.com
      • Principal Investigator: Lukasz Paprocki, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We plan to recruit all consecutive infants borned at 32 and 42 weeks of gestation.

Description

Inclusion Criteria:

- gestational age ≥32 weeks

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Investigators: Study Chair: Renata Bokiniec, M. D, Dr hab. n. med.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; newborn; anatomy; larynx; trachea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Tracheal Diseases
• Other Study ID Numbers: LARYNXUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial will be available, after deidentication. The study protocol will also be available.
• IPD Sharing Time Frame: June 2022 - December 2022
• IPD Sharing Access Criteria: Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No