Clinical Trials Directory

Trials / Completed

CompletedNCT02339519

A Comparison of Supraglottic Airway Devices

A Comparison of Supraglottic Airway Devices; Lma Classic, Lma Fastrach and Lma Supreme; a Prospective, Randomized, Clinical Trial of Efficacy, Safety and Complications

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Umraniye Education and Research Hospital · Other Government
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic complications.

Detailed description

As a result of studies regarding the provision of an airway which is less invasive than intubation but safer than mask to maintain patency of airway after anesthesia induction in brief surgical interventions, supraglottic airway devices have been introduced into practice. They are inserted to glottic entry via the oral route and can be used in emergent conditions where tracheal intubation and mask anesthesia are challenging. 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

Interventions

TypeNameDescription
DEVICELMA CLASSICClassic 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.
DEVICELMA FASTRACHFastrach 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.
DEVICELMA SUPREMESupreme 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.

Timeline

Start date
2015-01-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2015-01-15
Last updated
2015-12-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02339519. Inclusion in this directory is not an endorsement.