Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age >18 years.
- Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：标准口罩
在使用标准的药物治疗顺序进行全身麻醉诱导后，每位患者将进行面罩通气并进行分级（Han 和 Warters 量表）。面罩通气将在麻痹药物的标准给药前后进行评分。
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Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).
Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication.
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实验性的：Waters Mask
All anesthesiologists and CRNAs will view an instructional video on the use of the Warters Mask.. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).Mask ventilation will be scored before and after the standard administration of paralytic medication.
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All anesthesiologists and CRNAs will view an instructional video on the use of the Warters Mask.
Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Warters Scale Score
大体时间：one year
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The primary outcome will be the Warters Scale score for each mask, compared between patients.
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one year
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合作者和调查者
调查人员
- 首席研究员：Tod Brown, MD、Assistant Professor
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pro00047645
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Waters Mask的临床试验
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Northern Health and Social Care TrustAntrim Area Hospital完全的