Laryngeal Mask Airway Supreme Versus Laryngeal Tube

Laryngeal Mask Airway Supreme Versus Laryngeal Tube in Non-paralysed, Anesthetized Children. A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position Using the Size 2

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

Study Overview

• Status: Completed
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Device: Supreme; Device: Laryngeal Tube

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supreme; Supreme LMA	Device: Supreme; Device: Laryngeal Tube
Active Comparator: Laryngeal Tube; Laryngeal tube LTSII	Device: Supreme; Device: Laryngeal Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 Min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 Min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion	We allowed one attempt before considering a failure, defining failed insertion by any of the following criteria: 1) failed passage into the pharynx; 2) malposition (air leaks); and 3) ineffective ventilation (maximum expired tidal volume <4 ml kg-1 or end-tidal CO2 > 50 mm Hg (if correctly positioned). ). Insertion time was defined as the interval between picking up the prepared device and successfully placement. After placement effective ventilation was tested by observation of chest wall movement and capnometric curve trace. If insertion failed the etiology was signed on the CRF. After a first insertion attempt one single attempt with the guiding technique was allowed.	1 Min

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Collaborators: University of Salzburg
• Investigators: Principal Investigator: Christian Keller, MD, M.Sc., Schulthess Klinik, Lengghalde 2, 8008 Zürich

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Schulthess_Anä_4