Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- blood on the ProSeal LMA
研究概览
简要总结
The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
blood on the ProSeal LMA
时间窗: from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)
The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.
次要结局
- hemodynamic variables(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(after successful insertion of Proseal LMA)
- other intraoperative complications(from successful insertion of PLMA until the end of the anesthesia)
- postoperative complications(from removal of Proseal LMA until discharge from recovery room)
研究者
Kim Mihyun
professor
Seoul National University Bundang Hospital