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Laryngeal Mask Airway Supreme Versus Laryngeal Tube

S

Schulthess Klinik

Status

Completed

Conditions

Adverse Anesthesia Outcome

Treatments

Device: Laryngeal Tube
Device: Supreme

Study type

Interventional

Funder types

Other

Identifiers

NCT02252120
Schulthess_Anä_4

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 months to 9 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Supreme
Active Comparator group
Description:
Supreme LMA
Treatment:
Device: Laryngeal Tube
Device: Supreme
Laryngeal Tube
Active Comparator group
Description:
Laryngeal tube LTSII
Treatment:
Device: Laryngeal Tube
Device: Supreme

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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