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Clinical Trials/NCT07361042
NCT07361042
Not yet recruiting
Not Applicable

Comparison of Video and Classic Laryngeal Mask Airways: A Prospective Randomized Trial

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.0 sites417 target enrollmentStarted: April 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Enrollment
417
Primary Endpoint
Sealing pressure

Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

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

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.

Arms & Interventions

Video Laryngeal Mask

Experimental

This arm will have airway secured with SaCo video laryngeal mask.

Intervention: Video Laryngeal Mask SaCo VLM (Device)

Laryngeal Mask Supreme

Active Comparator

This group will have airway secured with traditional Supreme laryngeal mask.

Intervention: Laryngeal Mask Supreme (Device)

Laryngeal Mask Ambu

Active Comparator

Laryngeal Mask Ambu Aura Gain

Intervention: Laryngeal Mask Ambu Aura Gain (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Time to adequate ventilation(From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.)

Investigators

Sponsor
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michal Kalina

Deputy for science and research

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

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