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Three Inflation Methods of Ambú Auragain™ and Its Adverse Effects

NCT04795544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-01-11

No results posted yet for this study

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)

Conditions

  • Laryngeal Mask Airway

Interventions

PROCEDURE

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

  • NICOLÁS BROGLY, 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
2021-01-18
Primary Completion
2021-10-20
Completion
2021-10-30

Countries

  • Spain

Study Locations

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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 NCT04795544 on ClinicalTrials.gov