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

Airway Management, Anesthesia, General, Pediatric Anesthesia

supraglottic airway device, video laryngeal mask, SaCoVLM, LMA Supreme, Ambu AuraGain, oropharyngeal leak pressure, children

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.

Blind insertion of supraglottic airway devices is associated with a first-attempt success rate of about 85% and frequent suboptimal positioning, which may require repositioning or reinsertion and can lead to desaturation, laryngospasm or bronchospasm. The SaCoVLM combines a second-generation laryngeal mask with a video camera that visualises the laryngeal inlet and allows the position to be corrected without reinsertion. Design: prospective, parallel-group, randomised controlled superiority trial with three arms (SaCoVLM, LMA Supreme, Ambu AuraGain), conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Procedures: After confirmation of eligibility, written informed consent of the parent or legal guardian and pre-anaesthetic assessment, participants are randomised 1:1:1 using a computer-generated sequence with variable block sizes (Study Randomizer). Anaesthesia is induced with propofol and sufentanil at the discretion of the attending anaesthesiologist; neuromuscular blocking agents are not administered before device insertion and OLP measurement. Device size follows manufacturer weight-based recommendations; the dorsal surface is lubricated with water-based gel. In the SaCoVLM group, the integrated video display is used to visualise the laryngeal inlet and to verify and, if necessary, adjust the device position. A maximum of three insertion attempts is permitted; failure leads to conversion to tracheal intubation or a different supraglottic airway device. Cuff pressure is set to 40-60 cmH2O using a manual manometer. OLP is measured within 5 minutes after insertion once stable ventilation is achieved (manual mode, ventilation paused, fresh gas flow 10 L/min, APL valve set to 50 cmH2O; the airway pressure at which the manometer reading becomes stable is recorded). In the SaCoVLM group, video image quality (5-point Likert scale) and percentage of glottic opening (POGO) are recorded immediately after OLP measurement. Device function, need for repositioning or reinsertion and complications are recorded during surgery; blood staining is assessed after removal at the end of emergence. Blinding: the anaesthesiologists inserting the device are not blinded; statistical analysis is performed by investigators blinded to group allocation. Statistics: The primary hypothesis is tested by two pre-specified pairwise comparisons (SaCoVLM vs LMA Supreme and SaCoVLM vs Ambu AuraGain) using independent-samples t-tests (or Mann-Whitney U test), with Bonferroni-adjusted two-sided alpha of 0.025 per comparison. LMA Supreme vs Ambu AuraGain is reported descriptively. Secondary endpoints are exploratory (chi-square/Fisher exact test, t-test/Mann-Whitney U test). The primary analysis follows the intention-to-treat principle; a per-protocol analysis is a sensitivity analysis. Sample size: assuming mean OLP of 25 cmH2O (SD 5) for LMA Supreme and 29 cmH2O (SD 5) for SaCoVLM (minimal clinically important difference 4 cmH2O, Cohen's d 0.8), alpha 0.025 and 90% power, 41 evaluable patients per group are required; allowing 10% non-evaluable data, 45 patients per group (135 in total) will be enrolled.

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