Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SaCoVLM™ Video Laryngeal Mask.
- Who it may be relevant to
- Registry conditions: Airway Management, Tracheal Intubation, Anesthesia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study
Overview
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.
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.
Interventions
- Device SaCoVLM™ Video Laryngeal Mask
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Primary outcome measures
- First-Attempt Success Rate of SaCoVLM™ Insertion [Time frame: Within 10 minutes of airway intervention.]
- First-Attempt Success Rate of Orotracheal Intubation via SaCoVLM™ [Time frame: Within 10 minutes following SaCoVLM™ placement.]
Secondary outcome measures (5)
- Time to SaCoVLM™ Insertion [Time frame: During initial airway management (simulation or clinical setting).]
- Time to Successful Intubation [Time frame: During initial airway management (simulation or clinical setting).]
- Glottic Visualization Score [Time frame: Immediately after SaCoVLM™ placement.]
- Subjective Difficulty Score [Time frame: Immediately after each procedure.]
- Incidence of Airway Complications [Time frame: From initiation of airway management to induction of general anesthesia (clinical phase only).]
Eligibility criteria
Inclusion criteria
- Elective surgery
- ASA I-II
- need for airway management
Exclusion criteria
- Pregnancy
- known airway abnormalities
- allergy to anesthetics
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- Military University Hospital Prague — Prague
Publications
- 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 33029458
Identifiers
NCT: NCT07249983 · SAVER-2025