NCT03501095

Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy

Completed Last updated 1 February 2023

What this trial tests

trial testing Vocal analysis and Laryngostroboscopy in Intubation Complication in 480 participants. Completed in 31 March 2019.

Timeline

17 April 2018

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	Azienda Ospedaliero Universitaria Maggiore della Carita
Status	Completed
Study type	OBSERVATIONAL
Enrollment	480
Start date	17 April 2018
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across Italy

Drugs / interventions tested

• Vocal analysis and Laryngostroboscopy

Conditions studied

• Intubation Complication — all drugs for Intubation Complication →
• Vocal Cord Dysfunction — all drugs for Vocal Cord Dysfunction →
• Vocal Tone Disorder — all drugs for Vocal Tone Disorder →
• Intubation;Difficult — all drugs for Intubation;Difficult →

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita — full company profile →

Who can join

Adults 18 to 70, any sex, with Intubation Complication or Vocal Cord Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.