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

Not Applicable

Completed

Conditions: Efficacy of Oropharyngeal Seal Pressure

Interventions: Device: Proseal Laryngeal Mask Airway
Device: Guardian Laryngeal Mask

Registration Number: NCT02063516

Lead Sponsor: Tianjin Medical University General Hospital

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

Detailed Description: 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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proseal	Proseal Laryngeal Mask Airway	Device:Proseal Laryngeal Mask Airway
Guardian	Guardian Laryngeal Mask	Device: Guardian Laryngeal Mask

Primary Outcome Measures

Name	Time	Method
Oropharyngeal Seal Pressure	5 min	This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

Secondary Outcome Measures

Name	Time	Method
Anatomic Position	5 min	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.