The New Third Generation Video Laryngeal Mask Evaluation

NCT07007403 | Completed

• 1 other identifier: SACOVLM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.

Conditions

Supraglottic Airway

Keywords

supraglottic airway; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• First insertion attempt success rate

  First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment.

  From the start of the attempt to the end of the general anesthesia.

Secondary Outcomes (2)

• Time to adequate ventilation

  From the initiation of the first insertion attempt until the end of general anesthesia.

• Sealing pressure

  From adequate ventilation until removing of the laryngeal mask.

Study Arms (1)

SaCo VLM laryngeal mask

In this group the video laryngeal mask is used for securing airway.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing general anesthesia in the MNUL and Děčín Hospital.

You may qualify if:

• Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask.

You may not qualify if:

• Patient younger than 18 years.
• Patient with predicted difficult airway (MACOCHA score \> 2).
• Patient with a history of difficult airway.
• Patient requiring airway management with a method other than a laryngeal mask.
• Refusal or failure to sign the informed consent for study participation.
• Patient undergoing emergency surgery.
• Administration of muscle relaxants for LMA insertion.
• State Entropy value below 30 during LMA insertion.
• State Entropy value above 60 during LMA insertion.

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead

Study Sites (1)

Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.

Ústí nad Labem, Ústí Nad Labem Region, 40001, Czechia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy of medical director

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 14, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CZ (1)