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Completed

NCT Number: NCT01575236

A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

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Key information

Conditions

Adverse Anesthesia Outcome

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinik für Anästhesie

Innsbruck, Tyrol, 6020, Austria

About this study

The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1 or 2
  • Age 18-75 yr
  • Written informed consent

Exclusion criteria

  • Difficult airway
  • Non fasted
  • BMI > 35

Treatment and study plan

Guardian Laryngeal Mask

Device

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Other names: Guardian Laryngeal Mask, Umedaes

Supreme Laryngeal Mask Airway

Device

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Other names: Supreme Laryngeal Mask Airway, LMA Deutschland GmbH

Primary outcomes

  1. efficacy of oropharyngeal seal pressure

    Time frame: 5 min

    this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O

Secondary outcomes

  1. anatomic position

    Time frame: 5 min

    this will be determined fiberoptically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

  • Medical University Innsbruck

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2012
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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