Airway ManagementSAVERNCT07249983
Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics
A study testing SaCoVLM™ Video Laryngeal Mask in people with Airway Management and Tracheal Intubation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management, Tracheal Intubation, Anesthesia
- What is being tested?
- SaCoVLM™ Video Laryngeal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- ASA I-II
- need for airway management
Who cannot join
- Pregnancy
- known airway abnormalities
- allergy to anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Military University Hospital Prague
Prague, Prague, 16209
Michal Sotak, M.D., Ph.D., +420774830710, michal.sotak@uvn.cz
About this study
Official title: Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study
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.
Read the 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.
- Conditions
- Airway Management, Tracheal Intubation, Anesthesia
- Being tested
- SaCoVLM™ Video Laryngeal Mask
- Keywords
- SaCoVLM™, Video Laryngeal Mask, Military Medic Training, Emergency Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaCoVLM™ Video Laryngeal MaskDevice
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
| Study group | Role | What they receive |
|---|---|---|
| Simulation and Clinical Phase | Experimental | Simulation-based and clinical use of SaCoVLM™ for airway management and intubation. Receives: Device: SaCoVLM™ Video Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 10 minutes following SaCoVLM™ placement.
Secondary outcomes (5)
Time to SaCoVLM™ Insertion
Time in seconds from picking up the device to successful confirmation of placement.
Measured: During initial airway management (simulation or clinical setting).
Time to Successful Intubation
Time in seconds from introduction of the endotracheal tube into the SaCoVLM™ to confirmed tracheal placement.
Measured: 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.
Measured: Immediately after SaCoVLM™ placement.
Subjective Difficulty Score
Operator-rated difficulty of device use on a 10-point visual analog scale (VAS).
Measured: Immediately after each procedure.
Incidence of Airway Complications
Number of adverse airway events including hypoxemia (SpO₂ < 90%), laryngospasm, or aspiration.
Measured: From initiation of airway management to induction of general anesthesia (clinical phase only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Principal investigator, Michal Soták, Charles University, Czech Republic
- Investigators
- Michal Sotak, M.D., Ph.D., Principal investigator, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249983
- Sponsor's protocol ID
- SAVER-2025
- Acronym
- SAVER
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33029458
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study
- ClinicalTrials.gov ID
- NCT07249983
- Acronym / sponsor ID
- SAVER / SAVER-2025
- Conditions
- Airway Management, Tracheal Intubation, Anesthesia
- Keywords
- SaCoVLM™, Video Laryngeal Mask, Military Medic Training, Emergency Airway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation and Clinical Phase | Experimental | Device: SaCoVLM™ Video Laryngeal MaskSimulation-based and clinical use of SaCoVLM™ for airway management and intubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery
- ASA I-II
- need for airway management
Key exclusion criteria (3 listed)
- Pregnancy
- known airway abnormalities
- allergy to anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaCoVLM™ Video Laryngeal MaskSimulation-based and clinical use of SaCoVLM™ for airway management and intubation. | Device | Simulation and Clinical Phase |
Primary outcome
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.
5 secondary outcomes
Time to SaCoVLM™ Insertion
Time frame: During initial airway management (simulation or clinical setting).
Time to Successful Intubation
Time frame: During initial airway management (simulation or clinical setting).
Glottic Visualization Score
Time frame: Immediately after SaCoVLM™ placement.
Subjective Difficulty Score
Time frame: Immediately after each procedure.
Incidence of Airway Complications
Time frame: From initiation of airway management to induction of general anesthesia (clinical phase only).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 33029458Mishra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Sotak, M.D., Ph.D. principal investigator
Military University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaCoVLM™ Video Laryngeal Mask in people with Airway Management and Tracheal Intubation, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Palenik, M.D. (+420973203254, jan.palenik@uvn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Attempt Success Rate of SaCoVLM™ Insertion (time frame: Within 10 minutes of airway intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.