About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Video Laryngeal Mask SaCo VLM
DeviceVideo laryngeal mask third generation SaCoVLM will be used for airway management.
Laryngeal Mask Supreme
DeviceStandard laryngeal mask Supreme will be used for airway management.
Laryngeal Mask Ambu Aura Gain
DeviceLaryngeal Mask Ambu Aura Gain will be used in this group for airway management.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Other outcomes
First insertion attempt success rate
First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment.
Locations
Sponsors and contacts
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