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

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

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Injury
• Intervention / Treatment: Device: insertion of the PLMA; Device: insertion of the ProSeal LMA (PLMA)

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group size 4	Device: insertion of the PLMA; ProSeal LMA size 4 is inserted to the patients of Group size 4.; Other Names: insertion; ProSeal LMA size 4
Experimental: Group size 3; ProSeal LMA size 3 is inserted to the patients of Group size 3.	Device: insertion of the ProSeal LMA (PLMA); ProSeal LMA size 3 is inserted to the patients of Group size 3.; Other Names: insertion; ProSeal LMA size 3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Mihyun Kim, professor, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 24, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: ProSeal LMA 3 vs 4