Laryngeal Mask Airway Supreme Versus Laryngeal Tube

NCT ID: NCT02252120

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Adverse Anesthesia Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supreme

Supreme LMA

Group Type: ACTIVE_COMPARATOR

Supreme

Intervention Type: DEVICE

Laryngeal Tube

Intervention Type: DEVICE

Laryngeal Tube

Laryngeal tube LTSII

Group Type: ACTIVE_COMPARATOR

Supreme

Intervention Type: DEVICE

Laryngeal Tube

Intervention Type: DEVICE

Interventions

Supreme

Intervention Type: DEVICE

Laryngeal Tube

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salzburg

OTHER

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

ChristianKeller

PD Dr. med. M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Keller, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik, Lengghalde 2, 8008 Zürich

Other Identifiers

Schulthess_Anä_4

Identifier Type: -

Identifier Source: org_study_id