CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
intracuff pressure measurement +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04769791
NCT04769791N/ACompleted

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

Instituto de Investigación Hospital Universitario La Paz·interventional·Posted Feb 25, 2021·Updated Feb 26, 2021

In Brief

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

Detailed Summary

Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating room. The cuff inflating volume is not standardized and it is common practice to inflate the LMA cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the LMA 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 AuraOnce™ LMA during fibrobronchoscopy 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 (NVgroup)

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 25, 2021
Enrollment StartJul 17, 2017
Primary CompletionNov 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.4 years ago

Interventions

intracuff pressure measurementdevice

intracuff pressure is measured by a pressure manometer

intracuff pressure measurementdevice

intracuff pressure is measured by a pressure manometer

intracuff pressure measurementdevice

intracuff pressure is measured by a pressure manometer