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Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Summary
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.
Official title: Oropharyngeal Leak Pressure of the SaCoVLM Video Laryngeal Mask Compared With LMA Supreme and Ambu AuraGain in Paediatric Patients Undergoing General Anaesthesia: A Multicentre Randomised Controlled Trial
Key Details
Gender
All
Age Range
1 Month - 10 Years
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2026-11-01
Completion Date
2027-07-31
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
SaCoVLM video laryngeal mask
Airway management with the SaCoVLM video laryngeal mask (UE Medical, China), a second-generation supraglottic airway device with an integrated camera. The video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
LMA Supreme
Airway management with the LMA Supreme (Teleflex, USA), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
Ambu AuraGain
Airway management with the Ambu AuraGain (Ambu A/S, Denmark), a second-generation supraglottic airway device inserted using the standard blind technique. Size per manufacturer weight-based recommendation; cuff pressure 40-60 cmH2O.
Locations (1)
Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.
Ústí nad Labem, Czechia