A Comparison of Supraglottic Airway Devices

Umraniye Education and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Airway Management

Treatments: Device: LMA CLASSIC; Device: LMA SUPREME; Device: LMA FASTRACH

Study type: Interventional

Funder types: Other

Identifiers

NCT02339519

GK4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• normotensive patients with mouth aperture > 3 cm,
• thyromental distance > 6 cm,
• sternomental distance > 12.5 cm,
• body mass index < 35 kg m-2 were included in the study.

Exclusion criteria

• patients with ASA III-IV,
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 3 patient groups

group LMA supreme

Active Comparator group

Description:

Patients who received Laryngeal Mask Airway; LMA supreme

Treatment:

Device: LMA SUPREME

group LMA classic

Active Comparator group

Description:

Patients who received Laryngeal Mask Airway; LMA classic

Treatment:

Device: LMA CLASSIC

group Fastrach

Active Comparator group

Description:

Patients who received Laryngeal Mask Airway; LMA fastrach

Treatment:

Device: LMA FASTRACH