Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

N/ACompletedNCT02063516

Tianjin Medical University General Hospital80 enrolled

Overview

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Condition: The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients. Device: Guardian Laryngeal Mask Device: LMA Proseal Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Efficacy of Oropharyngeal Seal Pressure

Interventions

Guardian Laryngeal MaskDEVICE

Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.

Proseal Laryngeal Mask AirwayDEVICE

Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria:• Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II) * 18 to 65 years of age * Mallampati score less than 3 * thyromental distance more than 6.5 cm * mouth opening more than \>2.5 cm * a body mass index less than 35 kg/m2; Exclusion Criteria: * Body weight 50 Kg * Pregnancy * Difficult airway * Recent history of upper respiratory tract infection and sore throats * A history of esophageal reflux disease * ENT surgery * Laparoscopic surgery * Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Oropharyngeal Seal Pressure

This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

Time frame: 5 min

Secondary Outcomes

Anatomic Position

This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.

Time frame: 5 min

Data from ClinicalTrials.gov

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