Two-Phase Study of SaCoVLM12 Video Laryngeal Mask for Airway Management by Military Medics in Elective Surgery Patients

What this Trial Is About

Researchers are evaluating the SaCoVLM14 video laryngeal mask airway for airway management by military medics who have limited experience with intubation. This two-phase study aims to assess the devices performance, safety, and ease of use in both simulated and clinical settings. The goal is to determine if SaCoVLM14 can provide safe and effective airway management in resource-limited and prehospital military environments. The study includes two parts Phase 1 involves simulation-based training where medics practice intubation on manikins to evaluate device placement, visualization quality, and intubation success. Phase 2 involves clinical use of SaCoVLM14 in adult patients undergoing elective surgery under general anesthesia. The device is used for airway management and intubation, with measurements of first-attempt success rates, insertion and intubation times, glottic visualization, and complication rates. Participants will undergo assessments during both simulation and clinical phases, including timing of device insertion and intubation, visualization scoring, and difficulty rating. Safety is monitored by tracking airway complications from the start of airway management to anesthesia induction in the clinical phase. The study runs until January 2027 and involves adults aged 18 to 65 years undergoing elective surgery who require airway management.

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