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

April 17, 2026 updated by: Michal Soták, Charles University, Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Prague
      • Prague, Prague, Czechia, 16209
        • Recruiting
        • Military University Hospital Prague
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • known airway abnormalities
  • allergy to anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simulation and Clinical Phase
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Device: SaCoVLM™ Video Laryngeal Mask
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 10 minutes of airway intervention.
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.
Within 10 minutes following SaCoVLM™ placement.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During initial airway management (simulation or clinical setting).
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.
During initial airway management (simulation or clinical setting).
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.
Immediately after SaCoVLM™ placement.
Subjective Difficulty Score
Time Frame: Immediately after each procedure.
Operator-rated difficulty of device use on a 10-point visual analog scale (VAS).
Immediately after each procedure.
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.
From initiation of airway management to induction of general anesthesia (clinical phase only).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Military University Hospital, Prague

Investigators

  • Principal Investigator: Michal Sotak, M.D., Ph.D., Military University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAVER-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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