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NCT Number: NCT07249983

Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics

A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.

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Key information

Conditions

Airway Management Anesthesia Tracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military University Hospital Prague

Prague, 16209, Czechia

Location status: Recruiting

Location contact

Michal Sotak, M.D., Ph.D.

CONTACT

[email protected]

+420774830710

About this study

This prospective, two-phase study evaluates the use of the SaCoVLM™ video laryngeal mask airway by military medics with limited airway experience. Phase 1 involves simulated intubation on manikins to assess device placement, visualization quality, and intubation success. Phase 2 evaluates clinical performance in adult patients undergoing elective surgery under general anesthesia. Key outcomes include first-attempt success rates, insertion and intubation times, glottic visualization scores, and complication rates. The study aims to determine whether SaCoVLM™ can enable safe and effective airway management in resource-limited and prehospital military settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective surgery
  • ASA I-II
  • need for airway management

Exclusion criteria

  • Pregnancy
  • known airway abnormalities
  • allergy to anesthetics

Treatment and study plan

SaCoVLM™ video laryngeal mask

Device

Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Primary outcomes

  1. First-Attempt Success Rate of SaCoVLM™ Insertion

    Time frame: Within 10 minutes of airway intervention.

    Proportion of cases in which the SaCoVLM™ is successfully inserted on the first attempt during both simulated and clinical phases.

  2. First-Attempt Success Rate of Orotracheal Intubation via SaCoVLM™

    Time frame: Within 10 minutes following SaCoVLM™ placement.

    Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit.

Secondary outcomes

  1. Time to SaCoVLM™ Insertion

    Time frame: During initial airway management (simulation or clinical setting).

    Time in seconds from picking up the device to successful confirmation of placement.

  2. Time to Successful Intubation

    Time frame: During initial airway management (simulation or clinical setting).

    Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement.

  3. Glottic Visualization Score

    Time frame: Immediately after SaCoVLM™ placement.

    Laryngeal view quality assessed using Keller-Brimacombe scale. The Keller-Brimacombe score ranges from Grade 1 (vocal cords not visible) to Grade 4 (only vocal cords visible with a full, unobstructed view), with higher grades indicating better glottic visualization and alignment for intubation.

  4. Subjective Difficulty Score

    Time frame: Immediately after each procedure.

    Operator-rated difficulty of device use on a 10-point visual analog scale (VAS).

  5. Incidence of Airway Complications

    Time frame: From initiation of airway management to induction of general anesthesia (clinical phase only).

    Number of adverse airway events including hypoxemia (SpO₂ < 90%), laryngospasm, or aspiration.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Palenik, M.D.

CONTACT

[email protected]

+420973203254

Ladislav Šindelář, M.D.

CONTACT

[email protected]

+420973202999

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Official study title

Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study

Acronym: SAVER

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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