NCT02828280已完成不适用
A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.
Derek Sakata0 个研究点目标入组 44 人开始时间: 2011年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- Tidal Volume comparison
研究概览
简要总结
The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •44 adults total
- •ASA status I-III
- •aged 18-64
- •elective surgery at the University of Utah under general anesthesia
- •Bearded, BMI >35 or edentulous
排除标准
- •ASA IV or higher
- •Oropharyngeal or facial pathology
- •Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
- •Known and/or documented difficulty placing an endotracheal tube in the past
- •Limited neck extension or flexion
- •Personal or familial history of malignant hyperthermia
- •Known or predicted severe respiratory disease or compromise
- •Pregnancy
结局指标
主要结局
Tidal Volume comparison
时间窗: 2 minutes (one minute for NuMask, one minute for traditional mask)
Tidal volumes delivered between the two devices will be compared
次要结局
- Ease of use(2 minutes)
研究者
Derek Sakata
M.D.
University of Utah
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