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

Seoul National University Bundang Hospital154 enrolled

Overview

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

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

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

154

Conditions

Oropharyngeal Injury

Interventions

insertion of the ProSeal LMA (PLMA)DEVICE

ProSeal LMA size 3 is inserted to the patients of Group size 3.

insertion of the PLMADEVICE

ProSeal LMA size 4 is inserted to the patients of Group size 4.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

blood on the ProSeal LMA

The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.

Time frame: from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)

Secondary Outcomes

hemodynamic variables

mean arterial pressure and heart rate before and after the Proseal LMA insertion are measured.

Time frame: from induction of anesthesia until immediately after the Proseal LMA insertion

insertion time

Time frame: from grasping the Proseal LMA until an effective airway is established

seal pressure

oropharyngeal leak pressure

Time frame: after successful insertion of Proseal LMA

other intraoperative complications

airway leak, failed ventilation, regurgitation/aspiration, laryngospasm, cough/gag/retching/hiccup.

Time frame: from successful insertion of PLMA until the end of the anesthesia

postoperative complications

sore throat and hoarseness

Time frame: from removal of Proseal LMA until discharge from recovery room

Data from ClinicalTrials.gov

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