An interventional study of insertion of the ProSeal LMA (PLMA) and insertion of the PLMA in Oropharyngeal Injury, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by Seoul National University Bundang Hospital · Not applicable and Interventional
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.
Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: insertion of the PLMA
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.
Also known as: insertion, ProSeal LMA size 3
ProSeal LMA size 4 is inserted to the patients of Group size 4.
Also known as: insertion, ProSeal LMA size 4
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)
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
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital