Supraglottic AirwayVLMA vs LMANCT07361042
Comparison of Video and Classic Laryngeal Mask Airways
A study testing Video Laryngeal Mask SaCo VLM, Laryngeal Mask Supreme and Laryngeal Mask Ambu Aura Gain in people with Supraglottic Airway, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
Trial summary
The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraglottic Airway
- What is being tested?
- Video Laryngeal Mask SaCo VLM, Laryngeal Mask Supreme and Laryngeal Mask Ambu Aura Gain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask.
- Patient aged 18 years or older.
Who cannot join
- Patient younger than 18 years.
- Patient with predicted difficult airway (MACOCHA score > 2).
- Patient with a history of difficult airway.
- Patient requiring airway management with a method other than a laryngeal mask.
- Refusal or failure to sign the informed consent for study participation. • Patient undergoing emergency surgery.
- Administration of muscle relaxants for LMA insertion.
- State Entropy value below 30 during LMA insertion.
- State Entropy value above 60 during LMA insertion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Video and Classic Laryngeal Mask Airways: A Prospective Randomized Trial
The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.
Read the detailed description
First, informed consent for study participation will be obtained from the patient. The consent will be collected during the preoperative evaluation by the anesthesiologist responsible for providing anesthesia care during the surgical procedure, in the preoperative holding area.After obtaining informed consent, a routine preoperative assessment will be conducted by the anesthesiologist, including standard preparation procedures (e.g., establishing peripheral venous access, evaluation of airway management risk, etc.). Randomization will be performed using a computerized online tool (studyrandomizer.com).The patient will then be transferred to the operating room, where standard monitoring will be initiated in accordance with the principles of safe anesthesia care.Induction of anesthesia will follow, during which propofol and sufentanil will be administered in doses determined by the attending anesthesiologist. A muscle relaxant will not be used to facilitate insertion of the laryngeal mask airway (LMA). Once an adequate depth of anesthesia is achieved-defined by an entropy value of SE < 60-airway management will proceed according to the patient's assigned group (Group A - SaCoVLM; Group B - Supreme; Group C - Ambu).In both groups, the back of the LMA will be lubricated with a water-based gel. Group A will receive airway management using the SaCoVLM™ video laryngeal mask. Group B will receive airway management using the Supreme™ laryngeal mask and Group C will recieve airway management using the Ambu Aura Gain.The following data will be recorded: successful first attempt with adequate ventilation, time to initiation of ventilation, number of attempts required, SpO₂ at the time of ventilation onset, and EtCO₂ after initiation. Additionally, the fraction of oxygen in the exhaled gas mixture will be measured before the first insertion attempt and after achieving adequate ventilation. A gastric tube will be inserted via the drainage port in both groups.Surgery will then proceed. During the procedure, oropharyngeal leak pressure will be measured at the 10th and 20th minute following LMA insertion. Ventilation will continue using the inserted LMA throughout the procedure. At the end of surgery, anesthesia will be discontinued, and the LMA will be removed. Upon removal, the presence of blood-tinged secretions on the LMA will be noted.One hour after LMA removal, the patient will be assessed for oropharyngeal discomfort (e.g., sore throat, pain, cough irritation, or blood-streaked sputum). The need for oxygen therapy will also be recorded at 10 minutes and 1 hour following LMA removal. After this, the patient's participation in the study will conclude.
- Conditions
- Supraglottic Airway
- Being tested
- Video Laryngeal Mask SaCo VLM, Laryngeal Mask Supreme, Laryngeal Mask Ambu Aura Gain
- Keywords
- supraglottic airway, laryngeal mask, airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Laryngeal Mask SaCo VLMDevice
Also called VLMA, Video laryngeal mask
Video laryngeal mask third generation SaCoVLM will be used for airway management.
Laryngeal Mask SupremeDevice
Also called Supreme, laryngeal mask
Standard laryngeal mask Supreme will be used for airway management.
Laryngeal Mask Ambu Aura GainDevice
Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngeal Mask | Experimental | This arm will have airway secured with SaCo video laryngeal mask. Receives: Device: Video Laryngeal Mask SaCo VLM |
| Laryngeal Mask Supreme | Active comparator | This group will have airway secured with traditional Supreme laryngeal mask. Receives: Device: Laryngeal Mask Supreme |
| Laryngeal Mask Ambu | Active comparator | Laryngeal Mask Ambu Aura Gain Receives: Device: Laryngeal Mask Ambu Aura Gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealing pressure
The maximum sealing pressure that can be reach after insertion and optimal alignment of the laryngeal mask. The APL ventilator will be set to 70 mbar and after there will be plateau on the pressure curve the sealing pressure will be measured.
Measured: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.
Secondary outcomes (1)
Time to adequate ventilation
Time from start of the insertion attempt until the adequate ventilation is reached. Adequate ventilation is considered if there are three or more plateau readings in EtCO2 curve.
Measured: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic AirwayStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, Principal investigator, Masaryk Hospital Ústí nad Labem Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361042
- Sponsor's protocol ID
- SACOVLMRCT
- Acronym
- VLMA vs LMA
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be store in the depository of University of Jan Evangelista Purkynje in Ústí nad Labem.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video and Classic Laryngeal Mask Airways: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07361042
- Acronym / sponsor ID
- VLMA vs LMA / SACOVLMRCT
- Conditions
- Supraglottic Airway
- Keywords
- supraglottic airway, laryngeal mask, airway management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Jan 2026 (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.
The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.
Detailed description
First, informed consent for study participation will be obtained from the patient. The consent will be collected during the preoperative evaluation by the anesthesiologist responsible for providing anesthesia care during the surgical procedure, in the preoperative holding area.After obtaining informed consent, a routine preoperative assessment will be conducted by the anesthesiologist, including standard preparation procedures (e.g., establishing peripheral venous access, evaluation of airway management risk, etc.). Randomization will be performed using a computerized online tool (studyrandomizer.com).The patient will then be transferred to the operating room, where standard monitoring will be initiated in accordance with the principles of safe anesthesia care.Induction of anesthesia will follow, during which propofol and sufentanil will be administered in doses determined by the attending anesthesiologist. A muscle relaxant will not be used to facilitate insertion of the laryngeal mask airway (LMA). Once an adequate depth of anesthesia is achieved-defined by an entropy value of SE < 60-airway management will proceed according to the patient's assigned group (Group A - SaCoVLM; Group B - Supreme; Group C - Ambu).In both groups, the back of the LMA will be lubricated with a water-based gel. Group A will receive airway management using the SaCoVLM™ video laryngeal mask. Group B will receive airway management using the Supreme™ laryngeal mask and Group C will recieve airway management using the Ambu Aura Gain.The following data will be recorded: successful first attempt with adequate ventilation, time to initiation of ventilation, number of attempts required, SpO₂ at the time of ventilation onset, and EtCO₂ after initiation. Additionally, the fraction of oxygen in the exhaled gas mixture will be measured before the first insertion attempt and after achieving adequate ventilation. A gastric tube will be inserted via the drainage port in both groups.Surgery will then proceed. During the procedure, oropharyngeal leak pressure will be measured at the 10th and 20th minute following LMA insertion. Ventilation will continue using the inserted LMA throughout the procedure. At the end of surgery, anesthesia will be discontinued, and the LMA will be removed. Upon removal, the presence of blood-tinged secretions on the LMA will be noted.One hour after LMA removal, the patient will be assessed for oropharyngeal discomfort (e.g., sore throat, pain, cough irritation, or blood-streaked sputum). The need for oxygen therapy will also be recorded at 10 minutes and 1 hour following LMA removal. After this, the patient's participation in the study will conclude.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video Laryngeal Mask | Experimental | Device: Video Laryngeal Mask SaCo VLMThis arm will have airway secured with SaCo video laryngeal mask. |
| Laryngeal Mask Supreme | Active comparator | Device: Laryngeal Mask SupremeThis group will have airway secured with traditional Supreme laryngeal mask. |
| Laryngeal Mask Ambu | Active comparator | Device: Laryngeal Mask Ambu Aura GainLaryngeal Mask Ambu Aura Gain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask.
- Patient aged 18 years or older.
Key exclusion criteria (8 listed)
- Patient younger than 18 years.
- Patient with predicted difficult airway (MACOCHA score > 2).
- Patient with a history of difficult airway.
- Patient requiring airway management with a method other than a laryngeal mask.
- Refusal or failure to sign the informed consent for study participation. • Patient undergoing emergency surgery.
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 |
|---|---|---|
| Video Laryngeal Mask SaCo VLMAlso: VLMA, Video laryngeal maskVideo laryngeal mask third generation SaCoVLM will be used for airway management. | Device | Video Laryngeal Mask |
| Laryngeal Mask SupremeAlso: Supreme, laryngeal maskStandard laryngeal mask Supreme will be used for airway management. | Device | Laryngeal Mask Supreme |
| Laryngeal Mask Ambu Aura GainLaryngeal Mask Ambu Aura Gain will be used in this group for airway management. | Device | Laryngeal Mask Ambu |
Primary outcome
Sealing pressure
Time frame: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.
The maximum sealing pressure that can be reach after insertion and optimal alignment of the laryngeal mask. The APL ventilator will be set to 70 mbar and after there will be plateau on the pressure curve the sealing pressure will be measured.
1 secondary outcome
Time to adequate ventilation
Time frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
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 3 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be store in the depository of University of Jan Evangelista Purkynje in Ústí nad Labem.
Related trials for Supraglottic Airway
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A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
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Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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 Kalina principal investigator
Masaryk Hospital Ústí nad Labem Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngeal Mask SaCo VLM, Laryngeal Mask Supreme and Laryngeal Mask Ambu Aura Gain in people with Supraglottic Airway, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Michal Kalina, MUDr. (+420773628756, michalkalina41@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealing pressure (time frame: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.