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

Schulthess Klinik

Status and phase: Completed; Phase 3

Conditions: Adverse Anesthesia Outcome

Treatments: Device: Guardian Laryngeal Mask; Device: Supreme Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT01575236

Schulthess_Anä_3 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Difficult airway
• Non fasted
• BMI > 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Guardian

Experimental group

Description:

Guardian Laryngeal Mask

Treatment:

Device: Guardian Laryngeal Mask

Supreme

Experimental group

Description:

Supreme Laryngeal Mask Airway

Treatment:

Device: Supreme Laryngeal Mask Airway