MedTrace Logo

Three Inflation Methods of the Ambú Auraonce™ and Its Adverse Effects

NCT04769791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2021-02-26

No results posted yet for this study

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)

Conditions

  • Laryngeal Mask Airway

Interventions

DEVICE

intracuff pressure measurement

intracuff pressure is measured by a pressure manometer

DEVICE

intracuff pressure measurement

intracuff pressure is measured by a pressure manometer

DEVICE

intracuff pressure measurement

intracuff pressure is measured by a pressure manometer

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • TERESA PRIM MARTINEZ, MD · HOSPITAL La Paz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2018-11-21
Completion
2018-11-21

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04769791 on ClinicalTrials.gov