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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01575236

Enrollment

120

Registered

2012-04-11

Start date

2012-03-31

Completion date

2012-07-31

Last updated

2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

Brief summary

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.

Detailed 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.

Interventions

DEVICEGuardian Laryngeal Mask

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

DEVICESupreme Laryngeal Mask Airway

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Difficult airway * Non fasted * BMI \> 35

Design outcomes

Primary

Measure	Time frame	Description
efficacy of oropharyngeal seal pressure	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

Measure	Time frame	Description
anatomic position	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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026