CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 480 enrolled
Drug / intervention
Vocal analysis and Laryngostroboscopyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03501095
NCT03501095N/ACompleted

Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy: A Pilot Study

Azienda Ospedaliero Universitaria Maggiore della Carita·observational·Posted Apr 18, 2018·Updated Feb 1, 2023

In Brief

An observational study evaluating Vocal analysis and Laryngostroboscopy for Intubation Complication and 3 related conditions. Completed, enrolled 480 participants across 1 site.

Detailed Summary

The delicate structures of the larynx can be compromised by innumerable causes, one of these is represented by endotracheal intubation. More frequently, these damages are represented by hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause the onset of damage, some depending on the practice itself, such as size and type of endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration of the intervention; others from patient-related factors, such as gender, weight, history of exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of such symptoms varies from 0% to 18% among the general population, with an average of 6% with resolution of most of the symptoms within 72 hours unless substantial damage has occurred to the vocal cords or to the arytenoids. In general, the incidence of such laryngeal complications has been described by several studies, but there is no standardized protocol for measuring and evaluating their entity. The purpose of this study is to determine how the voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through voice analysis and laryngostroboscopy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2018
Enrollment StartApr 17, 2018
Primary CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.2 years ago

Interventions

Vocal analysis and Laryngostroboscopyother

Vocal analysis study the acoustic emission of the pneumo-phono-articulatory system, i.e. the vocal signal. Currently, digital technology instruments enable the processing and analysis of the verbal signal quickly and reliably, also offering graphical products and numerical data. Among the various existing software products for the study of the vocal signal, PRAAT is available. In practice, the vocal parameters are acquired in a non-invasive way with a microphone. Laryngostroboscopy is one of the most widely used techniques for laryngeal clinical evaluation. This is a non-invasive endoscopic practice performed by means of a flexible fibroscope, which, through a pulsed light source, allows visualization of the chordal movement.