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

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study

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

Study Overview

• Status: Completed
• Conditions: Efficacy of Oropharyngeal Seal Pressure
• Intervention / Treatment: Device: Guardian Laryngeal Mask; Device: Proseal Laryngeal Mask Airway

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)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guardian; Device: Guardian Laryngeal Mask	Device: Guardian Laryngeal Mask; 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.
Experimental: Proseal; Device:Proseal Laryngeal Mask Airway	Device: Proseal Laryngeal Mask Airway; Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Air Added to Keep Cuff Pressure 60cmH20.	The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.	30 minutes, 60 minutes, 90 minutes and 120 minutes

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Publications and helpful links

General Publications

• Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 10, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Airway Cuff; Guardian; Proseal; Cuff Pressure; laryngeal Mask Airway
• Other Study ID Numbers: Wang001