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Clinical Trials/NCT07249983
NCT07249983RecruitingNot Applicable

Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study

Charles University, Czech Republic1 site in 1 country50 target enrollmentStarted: March 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
First-Attempt Success Rate of SaCoVLM™ Insertion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Elective surgery
  • need for airway management

Exclusion Criteria

  • Pregnancy
  • known airway abnormalities
  • allergy to anesthetics

Arms & Interventions

Simulation and Clinical Phase

Experimental

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

Intervention: SaCoVLM™ Video Laryngeal Mask (Device)

Outcomes

Primary Outcomes

First-Attempt Success Rate of SaCoVLM™ Insertion

Time Frame: 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™

Time Frame: Within 10 minutes following SaCoVLM™ placement.

Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit.

Secondary Outcomes

  • Time to SaCoVLM™ Insertion(During initial airway management (simulation or clinical setting).)
  • Time to Successful Intubation(During initial airway management (simulation or clinical setting).)
  • Glottic Visualization Score(Immediately after SaCoVLM™ placement.)
  • Subjective Difficulty Score(Immediately after each procedure.)
  • Incidence of Airway Complications(From initiation of airway management to induction of general anesthesia (clinical phase only).)

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michal Soták

Principal Investigator

Charles University, Czech Republic

Study Sites (1)

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