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Clinical Trial Summary

There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures. The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.


Clinical Trial Description

Optimal use of extraglottic airways, including the laryngeal mask (LMA), has not been fully defined using real-world data. Usage patterns and the reported incidence of failure and complications in different geographic regions vary greatly. In the adult population, an observational study involving more than 15,000 cases revealed a 1.1% incidence of laryngeal mask failure, defined as intubation after laryngeal mask removal, and 62% of patients experienced significant airway complications. Similar data are scarce in children. Pediatric laryngeal mask studies report adverse event frequencies ranging from 0% to 10%. These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses. Additionally, although data on adverse events are presented, laryngeal mask failure requiring endotracheal intubation has been reported infrequently. There are a significant number of studies identifying risk factors for misplacement of LMAs. However, there are no objective data to define misplacement of LMAs. The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06337006
Study type Observational [Patient Registry]
Source Samsun University
Contact Hatice SELCUK KUSDERCI, 1
Phone 90 505 2159896
Email drkusderci@hotmail.com
Status Recruiting
Phase
Start date September 15, 2023
Completion date May 15, 2024

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