Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children

Study acronym: SACOVLM-PEDI
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Study First Submitted
This randomised controlled trial compares three supraglottic airway devices (laryngeal masks) in children with a body weight of 3-30 kg undergoing elective surgery under general anaesthesia: the SaCoVLM video laryngeal mask (UE Medical), which has an integrated camera allowing visual confirmation and adjustment of mask position, the LMA Supreme (Teleflex) and the Ambu AuraGain (Ambu). Children are randomly assigned in a 1:1:1 ratio to one of the three devices. The main question is whether the SaCoVLM provides a higher oropharyngeal leak pressure (a measure of how well the mask seals the airway) than the LMA Supreme and the Ambu AuraGain. Secondary questions include first-attempt insertion success, the need for repositioning or reinsertion of the mask during surgery and airway-related complications.
Trial Details
NCT Number NCT07891832
Lead Sponsor Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Collaborators: Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem, Charles University, Czech Republic
Conditions
(from sponsor)		 Airway Management, Anesthesia, General, Pediatric Anesthesia
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov