CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Larynx and trachea ultrasoundother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05636410
NCT05636410N/ACompleted

Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period

Princess Anna Mazowiecka Hospital, Warsaw, Poland·observational·Posted Dec 5, 2022·Updated Aug 14, 2024

In Brief

An observational study evaluating Larynx and trachea ultrasound for Larynx and Trachea. Completed, enrolled 300 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLarynx, Trachea
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedDec 5, 2022
Enrollment StartJun 14, 2022
Primary CompletionMay 28, 2023
Study CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.6 years ago

Interventions

Larynx and trachea ultrasoundother

After meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation.