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

Tianjin Medical University

Status

Completed

Conditions

Efficacy of Oropharyngeal Seal Pressure

Treatments

Device: Proseal Laryngeal Mask Airway

Device: Guardian Laryngeal Mask

Study type

Interventional

Funder types

Other

Identifiers

NCT02063516

Wang001

Details and patient eligibility

About

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

Full 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)

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.