Airway Management, Tracheal Intubation, Anesthesia
Conditions
Keywords
SaCoVLM™, Video Laryngeal Mask, Military Medic Training, Emergency Airway
Brief 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.
Interventions
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Sponsors
Charles University, Czech Republic
Military University Hospital, Prague
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Elective surgery * ASA I-II * need for airway management
Exclusion criteria
* Pregnancy * known airway abnormalities * allergy to anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Attempt Success Rate of SaCoVLM™ Insertion | Within 10 minutes of airway intervention. | Proportion of cases in which the SaCoVLM™ is successfully inserted on the first attempt during both simulated and clinical phases. |
| First-Attempt Success Rate of Orotracheal Intubation via SaCoVLM™ | Within 10 minutes following SaCoVLM™ placement. | Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to SaCoVLM™ Insertion | During initial airway management (simulation or clinical setting). | Time in seconds from picking up the device to successful confirmation of placement. |
| Time to Successful Intubation | During initial airway management (simulation or clinical setting). | Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement. |
| Glottic Visualization Score | Immediately after SaCoVLM™ placement. | 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. |
| Subjective Difficulty Score | Immediately after each procedure. | Operator-rated difficulty of device use on a 10-point visual analog scale (VAS). |
| Incidence of Airway Complications | From initiation of airway management to induction of general anesthesia (clinical phase only). | Number of adverse airway events including hypoxemia (SpO₂ \< 90%), laryngospasm, or aspiration. |
Countries
Czechia
Contacts
CONTACTJan Palenik, M.D.
CONTACTJosef Klecatsky, M.D.
PRINCIPAL_INVESTIGATORMichal Sotak, M.D., Ph.D.
Military University Hospital, Prague
Outcome results
None listed