NCT07249983

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Airway Management
• Tracheal Intubation
• Anesthesia

Interventions

Type	Name	Description
DEVICE	SaCoVLM™ Video Laryngeal Mask	Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2025-11-25
• Last updated: 2026-03-18

Locations

1 site across 1 country: Czechia