Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCharles University, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective surgery
ASA I-II
need for airway management
Disqualifiers
Pregnancy
known airway abnormalities
allergy to anesthetics
Trial design
Design model
Single group
Treatments tested in this trial
SaCoVLM™ Video Laryngeal Mask
DeviceSimulation-based and clinical use of SaCoVLM™ for airway management and intubation.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Simulation and Clinical PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 10 minutes of airway intervention.2
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.
Time frame
Within 10 minutes following SaCoVLM™ placement.Secondary outcomes
1
Time to SaCoVLM™ Insertion
Time in seconds from picking up the device to successful confirmation of placement.
Time frame
During initial airway management (simulation or clinical setting).2
Time to Successful Intubation
Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement.
Time frame
During initial airway management (simulation or clinical setting).3
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.
Time frame
Immediately after SaCoVLM™ placement.4
Subjective Difficulty Score
Operator-rated difficulty of device use on a 10-point visual analog scale (VAS).
Time frame
Immediately after each procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles University, Czech Republic
Lead sponsor
Military University Hospital, Prague
Collaborator
Source ClinicalTrials.gov