Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intubation Difficulty Scale(IDS) score
研究概览
简要总结
The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.
详细描述
The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-3 patients,
- •aged 20years or older,
- •undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.
排除标准
- •unstable teeth or mouth opening of < 18mm
- •Patients with any pathology of the neck,
- •upper respiratory tract or upper alimentary tracts,
- •risk of pulmonary aspiration of gastric contents,
- •a history of relevant drug allergy.
结局指标
主要结局
Intubation Difficulty Scale(IDS) score
时间窗: After the end of intubation (within 10 minute after the end of intubation.)
IDS score will be recorded within 10 minute after the end of intubation.
次要结局
- Cormack and Lehane grade(After the end of intubation (within 10 minute after the end of intubation.))
研究者
Mi Kyeong Kim
Assistant Professor
Kyunghee University Medical Center