ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients
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About
The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.
Full 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.
Enrollment
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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.
Trial design
154 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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