Laryngeal Mask Airway Supreme Versus Laryngeal Tube

Not Applicable

Completed

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Supreme; Device: Laryngeal Tube

• Registration Number: NCT02252120
• Lead Sponsor: Schulthess Klinik

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2014-01
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-26
• Last Update Submitted: 2014-09-26
• Study First Posted: 2014-09-29
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngeal Tube	Supreme	Laryngeal tube LTSII
Supreme	Supreme	Supreme LMA
Supreme	Laryngeal Tube	Supreme LMA
Laryngeal Tube	Laryngeal Tube	Laryngeal tube LTSII

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	5 Min	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).

Secondary Outcome Measures

Name	Time	Method
Fiberoptic position	5 Min	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)