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

Not Applicable

Completed

• Conditions: Oropharyngeal Injury
• Interventions: Device: insertion of the PLMA; Device: insertion of the ProSeal LMA (PLMA)

• Registration Number: NCT01184677
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• female
• aged 18-80 yr
• American Society of Anesthesiologists physical status Ⅰ-Ⅱ
• scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia

Exclusion Criteria

• a known or predicted difficult airway
• recent sore throat
• mouth opening less than 2.5 cm
• body mass index > 35 kg/m2
• at risk of aspiration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group size 4	insertion of the PLMA	-
Group size 3	insertion of the ProSeal LMA (PLMA)	ProSeal LMA size 3 is inserted to the patients of Group size 3.

Primary Outcome Measures

Name	Time	Method
blood on the ProSeal LMA	from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)	The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.

Secondary Outcome Measures

Name	Time	Method
hemodynamic variables	from induction of anesthesia until immediately after the Proseal LMA insertion	mean arterial pressure and heart rate before and after the Proseal LMA insertion are measured.
insertion time	from grasping the Proseal LMA until an effective airway is established
seal pressure	after successful insertion of Proseal LMA	oropharyngeal leak pressure
other intraoperative complications	from successful insertion of PLMA until the end of the anesthesia	airway leak, failed ventilation, regurgitation/aspiration, laryngospasm, cough/gag/retching/hiccup.
postoperative complications	from removal of Proseal LMA until discharge from recovery room	sore throat and hoarseness

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of