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临床试验/NCT03158207
NCT03158207已完成不适用

Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
2
主要终点
Warters Scale Score

研究概览

简要总结

Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic or apneic. Manual ventilation with a facemask is a skill that is routinely required for emergency medical technicians, respiratory therapists, nurses and physicians. Although mask ventilation skills are routinely taught, even the most skilled and experienced anesthesiologists struggle to effectively mask-ventilate.

The effective use of a standard mask requires the simultaneous establishment of a seal between the mask and face and the lifting of the jaw. The preferred grip is referred to as the C&E technique. The C&E technique requires the index finger and thumb to form a "C" and push down on the mask to establish a seal between the mask and face. The lateral three fingers form the "E" and wrap under the jaw to provide lift. The grip required to establish the seal and jaw lift simultaneously is awkward and difficult to teach. The basic design of the standard facemask has not changed in approximately 100 years.

This study will evaluate a new mask design, Warters Mask, is based on a novel design that allows a far more ergonomic grip. The C&E technique is replaced by a more natural grip. With the Warters Mask, downward pressure with the palm of the hand centered on the mask provides the seal between the face and the mask. The other four fingers align under the jaw to provide lift.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years.
  • Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.

排除标准

  • Need for awake intubation based on standard preoperative evaluation by the attending anesthesiologist.
  • Increased risk for aspiration of gastric contents due to full stomach, pregnancy, gastro-esophageal reflux disease, and/or hiatal hernia as identified during the pre-operative assessment.
  • Previous tracheostomy procedure.
  • Patient is cognitively incapable of providing their consent for the study.

结局指标

主要结局

Warters Scale Score

时间窗: one year

The primary outcome will be the Warters Scale score for each mask, compared between patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tod A. Brown

Assistant Professor

Medical University of South Carolina

研究点 (2)

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