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Not yet recruiting NCT07361042

Comparison of Video and Classic Laryngeal Mask Airways

No phase Interventional Supraglottic Airway

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video Laryngeal Mask SaCo VLM, Laryngeal Mask Supreme, Laryngeal Mask Ambu Aura Gain.
Who it may be relevant to
Registry conditions: Supraglottic Airway. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Video Laryngeal Mask SaCo VLM
    Video laryngeal mask third generation SaCoVLM will be used for airway management.
  • Device Laryngeal Mask Supreme
    Standard laryngeal mask Supreme will be used for airway management.
  • Device Laryngeal Mask Ambu Aura Gain
    Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.

Primary outcome measures

  • Sealing pressure [Time frame: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.]
Secondary outcome measures (1)
  • Time to adequate ventilation [Time frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07361042 · SACOVLMRCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗