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NCT04769791

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

Completed NA Last updated 26 February 2021
What this trial tests

NA trial testing intracuff pressure measurement in Laryngeal Mask Airway in 210 participants. Completed in 21 November 2018.

Timeline
17 July 2017
Primary endpoint
21 November 2018
21 November 2018

Quick facts

Lead sponsorInstituto de Investigación Hospital Universitario La Paz
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment210
Start date17 July 2017
Primary completion21 November 2018
Estimated completion21 November 2018
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

Adults 18 to 90, any sex, with Laryngeal Mask Airway. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of three inflation methods of the laryngeal mask airway Ambu® Auraonce™: a randomized controlled study.
    Prim T, Brogly N, Guasch E, Díez J, et al · · 2024 · PMID 37540323 · DOI 10.1007/s10877-023-01061-x
  2. Efficacy and Safety of Three Inflation Methods of the Laryngeal Mask Airway Ambu Auraonce: a Randomized Controlled Study
    Martínez TP, Brogly N, Guasch E, Díez J, et al · · 2023 · DOI 10.21203/rs.3.rs-2463230/v1

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing