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

NCT ID: NCT02063516

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-11-30

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)

Conditions

Efficacy of Oropharyngeal Seal Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Guardian

Device: Guardian Laryngeal Mask

Group Type: EXPERIMENTAL

Guardian Laryngeal Mask

Intervention Type: DEVICE

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

Device:Proseal Laryngeal Mask Airway

Group Type: EXPERIMENTAL

Proseal Laryngeal Mask Airway

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Proseal Laryngeal Mask Airway

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haiyun Wang

vice-Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25929558 (View on PubMed)

Other Identifiers

Wang001

Identifier Type: -

Identifier Source: org_study_id