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Recruiting Not applicable NCT07249983

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

No applicable phase (e.g. observational)
Conditions: Airway Management Tracheal Intubation Anesthesia

Sponsor: Charles University, Czech Republic

trial.available_in: БГ
Overview
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.
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.
Who can participate
Inclusion Criteria: * Elective surgery * ASA I-II * need for airway management Exclusion Criteria: * Pregnancy * known airway abnormalities * allergy to anesthetics
Interventions
SaCoVLM™ Video Laryngeal Mask
DEVICE
Locations 1
Czech Republic (1)
Military University Hospital Prague
Prague , Prague
Michal Sotak, M.D., Ph.D.
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.03.2026
Completion date
01.01.2027
Registry ID
NCT07249983
Source
clinicaltrials.gov
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