A Comparison of Supraglottic Airway Devices

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2015
• Main ID: NCT02339519
• Date of registration: 03/01/2015
• Prospective Registration: No
• Primary sponsor: Umraniye Education and Research Hospital
• Public title: A Comparison of Supraglottic Airway Devices
• Scientific title: A Comparison of Supraglottic Airway Devices; Lma Classic, Lma Fastrach and Lma Supreme; a Prospective, Randomized, Clinical Trial of Efficacy, Safety and Complications
• Date of first enrolment: January 2015
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02339519
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Erdal Komur, MD
• Affiliation: Istanbul Umraniye Education and Research Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Airway Management

Intervention(s)

Device: LMA CLASSIC

Device: LMA FASTRACH

Device: LMA SUPREME

Primary Outcome(s)

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). [Time Frame: 1 month]

Secondary Outcome(s)

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 [Time Frame: 1 month]

Composite measure of Hemodynamic parameters , change 20% from baseline in Mean Blood Pressure and Heart Rate [Time Frame: baseline and 1 month]

Number of Participants with oropharyngeal ( edema, haemorragie, blood in sputum) and systemic complications (anaflactic reactions) [Time Frame: 1 month]

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. [Time Frame: 1 monyh]

Secondary ID(s)

GK4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors