Laryngeal Mask Airway Supreme Versus Laryngeal Tube

Adverse Anesthesia Outcome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252120
• Other study ID #: Schulthess_Anä_4
• Status: Completed
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 26, 2014
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 9 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Supreme

• Laryngeal Tube

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	University of Salzburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes