NCT04259021

The Voice Analysis as a Preoperative Prediction Method of a Difficult Airway

Completed Last updated 28 September 2023

What this trial tests

trial in Difficult or Failed Intubation in 722 participants. Completed in 1 September 2022.

Timeline

1 March 2020

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	Fundacion Dexeus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	722
Start date	1 March 2020
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across Spain

Conditions studied

• Difficult or Failed Intubation — all drugs for Difficult or Failed Intubation →
• Voice — all drugs for Voice →
• Laryngoscopy — all drugs for Laryngoscopy →

Sponsor

Fundacion Dexeus — full company profile →

Who can join

18 and older, any sex, with Difficult or Failed Intubation or Voice. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Before an anesthetic procedure, airway management is essential to ensure adequate ventilation and breathing of the patient during the entire surgical process.

The preanesthetic evaluation of the airway allows for proper planning, facilitates the anticipation of human resources and necessary means to face the possible challenges in a safe and efficient way. Orofacial mask ventilation and endotracheal intubation are a crucial step in general anesthesia. Most of the time, management is not complicated, but when an unpredicted difficult airway occurs, it is currently one of the most important challenges to face as an anesthesiologist. These situations are rare as the prevalence of a difficult airway is approximately 2.2% of the general population.

When there is a case of a difficult airway and adequate management is not achieved, very serious complications may occur including brain damage, cardio-respiratory arrest, aspiration of gastric content, traumatic airway injuries, tooth damage, unnecessary surgical access to keep the airway permeable or death. For these reasons, in anesthesia, an unforeseen difficult airway is considered a crisis situation. Therefore, a preoperative airway assessment is paramount.

Traditional predictive tests evaluate multiple anthropometric characteristics in which the physical presence of the patient is mandatory. However, no test can currently predict a difficult airway based on a single characteristic nor in the patient's absence. Nowadays, the optimization of resources and new technologies have increased interest in developing new tests or methods for preoperatively assessing the difficulty of the airway and new methods of airway evaluation have been proposed. As recently demonstrated, the detection of a difficult airway depends not only on the morphology but also on functional traits of the airway. Some studies propose the analysis of voice parameters as a reflection of anatomical and functional features of the superior airway.

The investigators propose that the analysis of voice characteristics could reflect the airway's anatomy and therefore the investigators will be able to predict a difficult airway, and this would enable the development of a voice-based assessment method which could have an promising role in facilitating telematic airway evaluation.

Publications & conference data

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