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| Name | Class |
|---|---|
| Military University Hospital, Prague | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation and Clinical Phase | Experimental | Simulation-based and clinical use of SaCoVLM™ for airway management and intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SaCoVLM™ Video Laryngeal Mask | Device | Simulation-based and clinical use of SaCoVLM™ for airway management and intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| First-Attempt Success Rate of SaCoVLM™ Insertion | Proportion of cases in which the SaCoVLM™ is successfully inserted on the first attempt during both simulated and clinical phases. | Within 10 minutes of airway intervention. |
| First-Attempt Success Rate of Orotracheal Intubation via SaCoVLM™ | Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit. | Within 10 minutes following SaCoVLM™ placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to SaCoVLM™ Insertion | Time in seconds from picking up the device to successful confirmation of placement. | During initial airway management (simulation or clinical setting). |
| Time to Successful Intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Palenik, M.D. | Contact | +420973203254 | jan.palenik@uvn.cz | |
| Ladislav Šindelář, M.D. | Contact | +420973202999 | ladislav.sindelar@uvn.cz |
| Name | Affiliation | Role |
|---|---|---|
| Michal Sotak, M.D., Ph.D. | Military University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military University Hospital Prague | Recruiting | Prague | Prague | 16209 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33029458 | Background | Mishra N, Bharadwaj A. Comparison of Fiberoptic-Guided Tracheal Intubation Through Intubating Laryngeal Mask Airway (ILMA) FastrachTM and Ambu(R) Aura-i: A Randomized Clinical Study. Cureus. 2020 Sep 1;12(9):e10178. doi: 10.7759/cureus.10178. |
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Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement.
| During initial airway management (simulation or clinical setting). |
| Glottic Visualization Score | 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. | Immediately after SaCoVLM™ placement. |
| Subjective Difficulty Score | Operator-rated difficulty of device use on a 10-point visual analog scale (VAS). | Immediately after each procedure. |
| Incidence of Airway Complications | Number of adverse airway events including hypoxemia (SpO₂ < 90%), laryngospasm, or aspiration. | From initiation of airway management to induction of general anesthesia (clinical phase only). |