A Comparison of Supraglottic Airway Devices

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339519
• Other study ID #: GK4
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2015
• Last updated: December 7, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Umraniye Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of insertion will be rated using a 4-point scale (4: success at the first attempt without tactile resistance; 3: success at the first attempt with tactile resistance; 2: success at the second attempt; 1: failure at the second attempt).		1 month	Yes
Secondary	Composite measure of Hemodynamic parameters , change 20% from baseline in Mean Blood Pressure and Heart Rate		baseline and 1 month	Yes
Secondary	Number of Participants with oropharyngeal ( edema, haemorragie, blood in sputum) and systemic complications (anaflactic reactions)		1 month	Yes
Secondary	Time to successful insertion time and effective airway [ time to observation of 3 consequtive correct End-Tidal CO2 (EtCO2 )waves after insertion ] defined as insertion time and was recorded.		1 monyh	Yes
Secondary	Measure if the inserted device failed to provide adequate ventilation, the device position was changed within the oral cavity, which was then defined as repositioning		1 month	Yes