Laryngeal Mask Airway Supreme Versus Laryngeal Tube

Schulthess Klinik60 enrolled

Overview

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients

The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well studied laryngeal mask airway. Both devices have a drain tube to allow access to the gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The investigators hypothesized that design differences should lead to differences in efficacy of seal and anatomic position. In this randomized, crossover study, the investigators test the hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Adverse Anesthesia Outcome

Interventions

SupremeDEVICE

Laryngeal TubeDEVICE

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA I-II * age 1.5 - 9 years * minor surgery * extraglottic airway device Exclusion Criteria: * age (\<18 months, \>9 years) * weight (\<10 kg, \>25 kg) * a known difficult airway * risk of aspiration

Outcomes

Primary Outcomes

Oropharyngeal leak pressure

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

Time frame: 5 Min

Secondary Outcomes

Fiberoptic position

The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

Time frame: 5 Min

Data from ClinicalTrials.gov

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