Clinical Trial

Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population

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Record status
This record was last updated December 5, 2025 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this interventional study is to evaluate the clinical efficacy of SafeLM™, a video laryngeal mask airway device in paediatric population. The main questions it aims to answer are: 1. To determine the success rate, ease of device insertion, time for insertion, and how well the device seals the airway by measuring the oropharyngeal leak pressure (OPLP) of SafeLM™. 2. To determine the incidence of complication associated with SafeLM™ usage. 3. To study the association of glottic view with success rate and rate of complication. Participants perioperative clinical data will be collected for data analysis.
Trial Details
NCT Number NCT07266389
Lead Sponsor National University of Malaysia
Collaborators: University of Malaya
Conditions Anesthesia, Supraglottic Airway Efficiency, Paediatric Airway Management
Enrollment 60 participants
Start Date 2025-12-02
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-05