An interventional study of SaCoVLM video laryngeal mask and LMA Supreme in Airway Management, Anesthesia, General and Pediatric Anesthesia, sponsored by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.. Not yet recruiting at 1 site in Czechia. Open to participants aged 1 Month to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. · Not applicable, Interventional, and Supportive care
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.
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. is the lead sponsor of 21 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children randomised to airway management with the SaCoVLM video laryngeal mask, with video-guided verification and adjustment of device position.
Device: SaCoVLM video laryngeal mask
Children randomised to airway management with the LMA Supreme, inserted using the standard blind technique.
Device: LMA Supreme
Children randomised to airway management with the Ambu AuraGain, inserted using the standard blind technique.
Device: Ambu AuraGain
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.
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.
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.
Oropharyngeal leak pressure (OLP)
Airway pressure (cmH2O) at which the circuit manometer reading becomes stable, measured with the breathing circuit in manual mode, ventilation paused, fresh gas flow 10 L/min and the APL valve set to 50 cmH2O, after stable ventilation is achieved.
Time frame: From device insertion up to 5 minutes after insertion
First-attempt insertion success rate
Proportion of patients in whom the device is successfully inserted with adequate ventilation at the first attempt.
Time frame: From the start of the first insertion attempt until successful insertion (maximum 3 attempts), up to 10 minutes
Need for device repositioning or reinsertion during surgery
Proportion of patients requiring repositioning, reinsertion of the device or other airway intervention after successful insertion.
Time frame: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Incidence of perioperative airway-related complications
Proportion of patients with at least one of: desaturation (SpO2 \< 92%), laryngospasm, bronchospasm, aspiration; each complication also reported separately.
Time frame: From device insertion until device removal at the end of anaesthesia, up to 5 hours
Blood staining of the device on removal
Proportion of patients with visible blood on the device or in secretions after device removal.
Time frame: At device removal at the end of emergence from anaesthesia, up to 5 hours after insertion
Video image quality (SaCoVLM group only)
Quality of the video image of the integrated display rated by the inserting anaesthesiologist on a 5-point Likert scale (1 = worst, 5 = best; image quality only).
Time frame: Immediately after OLP measurement, up to 5 minutes after device insertion
Percentage of glottic opening (POGO) (SaCoVLM group only)
Percentage of the glottic opening visible on the integrated video display (0-100%).
Time frame: Immediately after OLP measurement, up to 5 minutes after device insertion
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.