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

Adverse Anesthesia Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575236
• Other study ID #: Schulthess_Anä_3
• Secondary ID: Schulthess_Anä_3
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2012
• Last updated: August 6, 2012
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA 1 or 2

• Age 18-75 yr

• Written informed consent

Exclusion Criteria:

• Difficult airway

• Non fasted

• BMI > 35

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Guardian Laryngeal Mask
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
• Supreme Laryngeal Mask Airway
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Locations

Country	Name	City	State
Austria	Universitätsklinik für Anästhesie	Innsbruck	Tirol

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of oropharyngeal seal pressure	this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O	5 min	Yes
Secondary	anatomic position	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	5 min	Yes