Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway (Supreme)
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ClinicalTrials.gov Identifier: NCT00626951 |
Recruitment Status
:
Completed
First Posted
: February 29, 2008
Last Update Posted
: July 3, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Paralysis | Device: LMA Supreme Device: LMA ProSeal | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Care Provider) |
Primary Purpose: | Treatment |
Official Title: | The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
LMA Supreme
|
Device: LMA Supreme
Extraglottic airway devices
|
Experimental: 2
LMA ProSeal
|
Device: LMA ProSeal |
- Oropharyngeal leak pressure [ Time Frame: 5 min ]
- Ease of insertion [ Time Frame: 1 min ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- American Society of Anesthesiology physical status grade I-II
- Age 18-80 yr
- Elective gynecological surgery
- Supine position
Exclusion Criteria:
- Known or predicted difficult airway
- Body mass index >35 kg m-2
- Risk of aspiration

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): NCT00626951
Austria | |
Medical University Innsbruck | |
Innsbruck, Tyrol, Austria, 6020 |
Principal Investigator: | Christian Keller, MD, MSc | Medical University Innsbruck |
Responsible Party: | Christian Keller MD MSc, Medical University Innsbruck |
ClinicalTrials.gov Identifier: | NCT00626951 History of Changes |
Other Study ID Numbers: |
07208763-1 |
First Posted: | February 29, 2008 Key Record Dates |
Last Update Posted: | July 3, 2008 |
Last Verified: | June 2008 |
Keywords provided by Medical University Innsbruck:
LMA Supreme LMA ProSeal Laryngeal mask airway Ventilation |
Additional relevant MeSH terms:
Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Disinfectants |