Comparison of Video and Classic Laryngeal Mask Airways

NCT07361042 | Not Yet Recruiting

• 1 other identifier: SACOVLMRCT
• Study Type: interventional
• Target: 417
• Locations: 0 countries
• Sites: N/A

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; airway management

Outcome Measures

Primary Outcomes (1)

• Sealing pressure

  The maximum sealing pressure that can be reach after insertion and optimal alignment of the laryngeal mask. The APL ventilator will be set to 70 mbar and after there will be plateau on the pressure curve the sealing pressure will be measured.

  After achieving adequate ventilation, and at 10 and 20 minutes thereafter.

Secondary Outcomes (1)

• Time to adequate ventilation

  From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Other Outcomes (1)

• First insertion attempt success rate

  From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Study Arms (3)

Video Laryngeal Mask

EXPERIMENTAL

This arm will have airway secured with SaCo video laryngeal mask.

Device: Video Laryngeal Mask SaCo VLM

Laryngeal Mask Supreme

ACTIVE COMPARATOR

This group will have airway secured with traditional Supreme laryngeal mask.

Device: Laryngeal Mask Supreme

Laryngeal Mask Ambu

ACTIVE COMPARATOR

Laryngeal Mask Ambu Aura Gain

Device: Laryngeal Mask Ambu Aura Gain

Interventions

Laryngeal Mask Supreme DEVICE

Standard laryngeal mask Supreme will be used for airway management.

Also known as: Supreme, laryngeal mask

Laryngeal Mask Supreme

Video Laryngeal Mask SaCo VLM DEVICE

Video laryngeal mask third generation SaCoVLM will be used for airway management.

Also known as: VLMA, Video laryngeal mask

Video Laryngeal Mask

Laryngeal Mask Ambu Aura Gain DEVICE

Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.

Laryngeal Mask Ambu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Patient aged 18 years or older.

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

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Michal Kalina

  Masaryk Hospital Ústí nad Labem Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Kalina, MUDr.

CONTACT

+420773628756; michalkalina41@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy for science and research

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be shared in the university repository for five years after completion of the study.
• Access Criteria: Data will be public in the University depositroy.