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

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ClinicalTrials.gov Identifier: NCT01575236
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : August 8, 2012
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik

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.

Condition or disease Intervention/treatment Phase
Adverse Anesthesia Outcome Device: Guardian Laryngeal Mask Device: Supreme Laryngeal Mask Airway Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Guardian
Guardian Laryngeal Mask
Device: Guardian Laryngeal Mask
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
Other Name: Guardian Laryngeal Mask, Umedaes

Experimental: Supreme
Supreme Laryngeal Mask Airway
Device: Supreme Laryngeal Mask Airway
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
Other Name: Supreme Laryngeal Mask Airway, LMA Deutschland GmbH




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Difficult airway
  • Non fasted
  • BMI > 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575236


Locations
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Austria
Universitätsklinik für Anästhesie
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Schulthess Klinik
Medical University Innsbruck
Investigators
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Study Chair: Christian Keller, MD MSc Anästhesie Schulthess Klinik
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Responsible Party: ChristianKeller, MD, M.Sc., Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01575236    
Other Study ID Numbers: Schulthess_Anä_3
Schulthess_Anä_3 ( Other Identifier: Schulthess Klinik )
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants