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Completed

NCT Number: NCT02252120

Laryngeal Mask Airway Supreme Versus Laryngeal Tube

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

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Key information

Conditions

Adverse Anesthesia Outcome

Age range

18 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supreme

Device

Laryngeal tube

Device

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 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 outcomes

  1. Fiberoptic position

    Time frame: 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)

Other outcomes

  1. Ease of insertion

    Time frame: 1 Min

    We allowed one attempt before considering a failure, defining failed insertion by any of the following criteria:

    • 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.

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

  • University of Salzburg

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2014
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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