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

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

Detailed Description
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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.

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

Conditions
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Oropharyngeal Injury

Intervention / Treatment
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* Device: insertion of the ProSeal LMA (PLMA)
* Device: insertion of the PLMA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group size 4<br> | Device: insertion of the PLMA<br>* ProSeal LMA size 4 is inserted to the patients of Group size 4.<br>* Other names: ProSeal LMA size 4;|
| Experimental: Group size 3<br>ProSeal LMA size 3 is inserted to the patients of Group size 3. | Device: insertion of the ProSeal LMA (PLMA)<br>* ProSeal LMA size 3 is inserted to the patients of Group size 3.<br>* Other names: ProSeal LMA size 3;|

What is the study measuring?
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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 |