NCT01184677

ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients

Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.

Detailed description

The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood. The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.

Conditions

• Oropharyngeal Injury

Interventions

Type	Name	Description
DEVICE	insertion of the ProSeal LMA (PLMA)	ProSeal LMA size 3 is inserted to the patients of Group size 3.
DEVICE	insertion of the PLMA	ProSeal LMA size 4 is inserted to the patients of Group size 4.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2010-08-19
• Last updated: 2012-08-27

Locations

1 site across 1 country: South Korea