Comparison of Video and Classic Laryngeal Mask Airways (VLMA vs LMA)

February 27, 2026 updated by: Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Laryngeal Mask
This arm will have airway secured with SaCo video laryngeal mask.
Device: Video Laryngeal Mask SaCo VLM
Video laryngeal mask third generation SaCoVLM will be used for airway management.
Other Names:
  • VLMA
  • Video laryngeal mask
Active Comparator: Laryngeal Mask Supreme
This group will have airway secured with traditional Supreme laryngeal mask.
Device: Laryngeal Mask Supreme
Standard laryngeal mask Supreme will be used for airway management.
Other Names:
  • laryngeal mask
  • Supreme
Active Comparator: Laryngeal Mask Ambu
Laryngeal Mask Ambu Aura Gain
Device: Laryngeal Mask Ambu Aura Gain
Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After achieving adequate ventilation, and at 10 and 20 minutes thereafter.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to adequate ventilation
Time Frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
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.
From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
First insertion attempt success rate
Time Frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment.
From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Investigators

  • Principal Investigator: Michal Kalina, Masaryk Hospital Ústí nad Labem Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SACOVLMRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be store in the depository of University of Jan Evangelista Purkynje in Ústí nad Labem.

IPD Sharing Time Frame

The data will be shared in the university repository for five years after completion of the study.

IPD Sharing Access Criteria

Data will be public in the University depositroy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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