Comparison of Video and Classic Laryngeal Mask Airways

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Video Laryngeal Mask SaCo VLM

    Device

    Video laryngeal mask third generation SaCoVLM will be used for airway management.

  • Laryngeal Mask Supreme

    Device

    Standard laryngeal mask Supreme will be used for airway management.

  • Laryngeal Mask Ambu Aura Gain

    Device

    Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.

Treatment groups

417 Participants
are divided into 3 treatment groups
Group A: Video Laryngeal MaskExperimental treatment 1 intervention
Group B: Laryngeal Mask SupremeActive comparator 1 intervention
Group C: Laryngeal Mask AmbuActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
After achieving adequate ventilation, and at 10 and 20 minutes thereafter.

Secondary outcomes

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.

Time frame
From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Other outcomes

1

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.

Time frame
From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.

Locations

This trial has no locations.

Sponsors and contacts

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