Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2015-01-31
2015-06-30
Brief Summary
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Detailed Description
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Classic LMA was first introduced by Archie Brain, MD in 1988, and consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
Fastrach LMA ( LMA Fastrach: LMA North America. Inc. San Diego. CA) was first introduced in 1997 and has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
Supreme LMA, first introduced in April, 2007, is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner because of the advanced cuff and airway tube. The integrated gastric canal facilitates gastric aspiration.
Supraglottic airway devices seem to have advantages over each other in different aspects due to their distinct features. In literature, there are studies comparing various LMA types for different features. However, to best of our knowledge, there is no study comparing these 3 types of LMA regarding these parameter. This is the main point of difference of our study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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group LMA supreme
Patients who received Laryngeal Mask Airway; LMA supreme
LMA SUPREME
Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.
group LMA classic
Patients who received Laryngeal Mask Airway; LMA classic
LMA CLASSIC
Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
group Fastrach
Patients who received Laryngeal Mask Airway; LMA fastrach
LMA FASTRACH
Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
Interventions
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LMA CLASSIC
Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
LMA FASTRACH
Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
LMA SUPREME
Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.
Eligibility Criteria
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Inclusion Criteria
* thyromental distance \> 6 cm,
* sternomental distance \> 12.5 cm,
* body mass index \< 35 kg m-2 were included in the study.
Exclusion Criteria
* those with a history of gastroesophageal reflux,
* pregnancy,
* cardiovascular and central nerve system disease,
* those with difficulty in cooperation,
* those undergoing intracranial, intraabdominal and Ear-nose-throat surgeries were excluded from study.
None of the methods changed after commencement of the study.
18 Years
70 Years
ALL
Yes
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Gulsah Karaoren
MD
Principal Investigators
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Erdal Komur, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Umraniye Education and Research Hospital
Locations
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Istanbul Umraniye Education and Research Hospital
Istanbul, Turkey, Turkey (Türkiye)
Countries
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References
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Timmermann A, Cremer S, Heuer J, Braun U, Graf BM, Russo SG. [Laryngeal mask LMA Supreme. Application by medical personnel inexperienced in airway management]. Anaesthesist. 2008 Oct;57(10):970-5. doi: 10.1007/s00101-008-1425-8. German.
Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
Other Identifiers
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GK4
Identifier Type: -
Identifier Source: org_study_id