Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics
SAVER
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 21, 2026
April 1, 2026
9 months
November 18, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
First-Attempt Success Rate of SaCoVLM™ Insertion
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™
Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit.
Within 10 minutes following SaCoVLM™ placement.
Secondary Outcomes (5)
Time to SaCoVLM™ Insertion
During initial airway management (simulation or clinical setting).
Time to Successful Intubation
During initial airway management (simulation or clinical setting).
Glottic Visualization Score
Immediately after SaCoVLM™ placement.
Subjective Difficulty Score
Immediately after each procedure.
Incidence of Airway Complications
From initiation of airway management to induction of general anesthesia (clinical phase only).
Study Arms (1)
Simulation and Clinical Phase
EXPERIMENTALSimulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Interventions
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Eligibility Criteria
You may qualify if:
- Elective surgery
- ASA I-II
- need for airway management
You may not qualify if:
- Pregnancy
- known airway abnormalities
- allergy to anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military University Hospital Prague
Prague, Prague, 16209, Czechia
Related Publications (1)
Mishra N, Bharadwaj A. Comparison of Fiberoptic-Guided Tracheal Intubation Through Intubating Laryngeal Mask Airway (ILMA) FastrachTM and Ambu(R) Aura-i: A Randomized Clinical Study. Cureus. 2020 Sep 1;12(9):e10178. doi: 10.7759/cureus.10178.
PMID: 33029458BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Michal Sotak, M.D., Ph.D.
Military University Hospital, Prague
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 18, 2025
First Posted
November 25, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share