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

NCT07891832 | Not Yet Recruiting

• 2 other identifiers: SACOVLM-PEDIIGA-KZ-2025-1-4
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Management; Anesthesia, General; Pediatric Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From device insertion up to 5 minutes after insertion

Secondary Outcomes (6)

• First-attempt insertion success rate

  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

  From device insertion until device removal at the end of anaesthesia, up to 5 hours

• Incidence of perioperative airway-related complications

  From device insertion until device removal at the end of anaesthesia, up to 5 hours

• Blood staining of the device on removal

  At device removal at the end of emergence from anaesthesia, up to 5 hours after insertion

• Video image quality (SaCoVLM group only)

  Immediately after OLP measurement, up to 5 minutes after device insertion

Study Arms (3)

SaCoVLM

EXPERIMENTAL

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

LMA Supreme

ACTIVE COMPARATOR

Children randomised to airway management with the LMA Supreme, inserted using the standard blind technique.

Device: LMA Supreme

Ambu AuraGain

ACTIVE COMPARATOR

Children randomised to airway management with the Ambu AuraGain, inserted using the standard blind technique.

Device: Ambu AuraGain

Interventions

SaCoVLM video laryngeal mask DEVICE

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.

SaCoVLM

LMA Supreme DEVICE

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.

LMA Supreme

Ambu AuraGain DEVICE

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.

Ambu AuraGain

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patients scheduled for elective surgery under general anaesthesia with a supraglottic airway device
• Body weight 3-30 kg (supraglottic airway device sizes 1-2.5)
• Written informed consent of the parent or legal guardian

You may not qualify if:

• Body weight \< 3 kg or \> 30 kg
• Anticipated difficult airway
• History of difficult airway
• Indication for airway management by a method other than a supraglottic airway device
• Emergency surgery
• Absence of written informed consent of the parent or legal guardian

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead
• Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.

Ústí nad Labem, 400 11, Czechia

Location

Related Publications (3)

• Gao X, Liu JH, Chen CM, Wang Y, Wang ZY, Yan CL, Zuo MZ, Cao Y, Qiao X, Huang YQ, Liu PC, Zhang H, Zhang JQ, Shen JM, Li C, Wang Y, Sun YY, Song JN, Zhang XZ, Zhang YL, Luo XT, Wu LN, Zhang Y, Shi L, Zhang Y, Xue FS, Tian M. Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial. Expert Rev Med Devices. 2022 Aug;19(8):649-656. doi: 10.1080/17434440.2022.2130048. Epub 2022 Oct 5.

  PMID: 36200143 BACKGROUND

• Sun Y, Zhang M, Gao X, Gao Z, Zou T, Guo Y, Liu M, Chen L, Zhang X, Liu Y, Feng H, Wang Y. Effect of the new video laryngeal mask airway SaCoVLM on airway management in lateral laparoscopic urological surgery: A single center randomized controlled trial. Sci Rep. 2024 Jan 25;14(1):2132. doi: 10.1038/s41598-024-51856-4.

  PMID: 38272937 BACKGROUND

• Yan CL, Chen Y, Sun P, Qv ZY, Zuo MZ. Preliminary evaluation of SaCoVLM video laryngeal mask airway in airway management for general anesthesia. BMC Anesthesiol. 2022 Jan 3;22(1):3. doi: 10.1186/s12871-021-01541-0.

  PMID: 34979936 BACKGROUND

Study Officials

• Michal Kalina, MD, PhD, MBA

  Masaryk Hospital Usti nad Labem, Krajska zdravotni a.s.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Kalina, MD, PhD, MBA

CONTACT

+420477111111; michal.kalina@kzcr.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The device cannot be masked for the anaesthesiologist inserting it. Statistical analysis is performed by investigators blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MBA, Deputy for Science and Research

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CZ (1)