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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group size 4 | Placebo Comparator |
| |
| Group size 3 | Experimental | ProSeal LMA size 3 is inserted to the patients of Group size 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insertion of the ProSeal LMA (PLMA) | Device | ProSeal LMA size 3 is inserted to the patients of Group size 3. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihyun Kim, professor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| insertion of the PLMA | Device | ProSeal LMA size 4 is inserted to the patients of Group size 4. |
|
|
| 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 |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |