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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Military University Hospital Prague
Prague, Czechia
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.
Time frame: 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.
Time frame: Within 10 minutes following SaCoVLM™ placement.
Time to SaCoVLM™ Insertion
Time in seconds from picking up the device to successful confirmation of placement.
Time frame: During initial airway management (simulation or clinical setting).
Time to Successful Intubation
Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement.
Time frame: During initial airway management (simulation or clinical setting).
Glottic Visualization Score
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.
Time frame: Immediately after SaCoVLM™ placement.
Subjective Difficulty Score
Operator-rated difficulty of device use on a 10-point visual analog scale (VAS).
Time frame: Immediately after each procedure.
Incidence of Airway Complications
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Number of adverse airway events including hypoxemia (SpO₂ \< 90%), laryngospasm, or aspiration.
Time frame: From initiation of airway management to induction of general anesthesia (clinical phase only).