Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- First-Attempt Success Rate of SaCoVLM™ Insertion
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective surgery
- •need for airway management
Exclusion Criteria
- •Pregnancy
- •known airway abnormalities
- •allergy to anesthetics
Arms & Interventions
Simulation and Clinical Phase
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Intervention: SaCoVLM™ Video Laryngeal Mask (Device)
Outcomes
Primary Outcomes
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.
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
- 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).)
Investigators
Michal Soták
Principal Investigator
Charles University, Czech Republic