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

Charles University, Czech Republic

Status: Not yet enrolling

Conditions: Tracheal Intubation; Airway Management; Anesthesia

Treatments: Device: SaCoVLM™ Video Laryngeal Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT07249983

SAVER-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective surgery
• ASA I-II
• need for airway management

Exclusion criteria

• Pregnancy
• known airway abnormalities
• allergy to anesthetics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Simulation and Clinical Phase

Experimental group

Description:

Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Treatment:

Device: SaCoVLM™ Video Laryngeal Mask