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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..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Michal Kalina, MUDr. contact

+420773628756

michalkalina41@gmail.com

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.

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 groups in NCT07361042
Study groupRoleWhat they receive
Video Laryngeal MaskExperimentalThis arm will have airway secured with SaCo video laryngeal mask.
Receives: Device: Video Laryngeal Mask SaCo VLM
Laryngeal Mask SupremeActive comparatorThis group will have airway secured with traditional Supreme laryngeal mask.
Receives: Device: Laryngeal Mask Supreme
Laryngeal Mask AmbuActive comparatorLaryngeal 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.

  1. 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)
  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.

  1. First posted22 Jan 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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.

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.

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