CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
Intracuff pressure measurementprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04795544
NCT04795544N/ACompleted

Three Inflation Methods of the Laryngeal Mask Airway Ambú Auragain™ and Its Pharyngolaryngeal Adverse Effects

Instituto de Investigación Hospital Universitario La Paz·interventional·Posted Mar 12, 2021·Updated Jan 11, 2022

In Brief

A clinical study evaluating Intracuff pressure measurement for Laryngeal Mask Airway. Completed, enrolled 210 participants across 1 site.

Detailed Summary

Laryngeal mask is a common supraglottic device (SGD) used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use. At the moment, the SGD is being used in several situations, which include general anesthesia, cardiopulmonary resuscitation, and difficult airway management. To insert the SGD safely in these situations, the Fourth National Audit Project has encouraged the use of second-generation SGD equipped with the passage of a nasogastric tube. Ambu Auragain™ is a recent second-generation SGD with an incorporated gastric drainage channel and the capability of working as a conduit for tracheal intubation. It has higher leak pressure than the ones of first generation, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway. However, there are still few reports of which volume of cuff is the most appropriate for it use. The cuff inflating volume is not standardized and it is common practice to inflate the SGD cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the laryngeal mask cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation. The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM \< 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications. The Primary outcome is to compare three different cuff inflating methods using Auragain™ laryngeal mask during fibro bronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications. The three different cuff inflating methods are: 1) residual volume group (RV group ) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NV group)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 12, 2021
Enrollment StartJan 18, 2021
Primary CompletionOct 20, 2021
Study CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

Intracuff pressure measurementprocedure

Intracuff pressure is measured by a pressure manometer.