Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percent Air Leakage During Bag-mask Ventilation
研究概览
简要总结
Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation in this anesthetized population.
详细描述
This study is a prospective crossover trial in bearded patients who will undergo elective or urgent surgery at the main operating rooms of the University of New Mexico Hospital.
It is planned to test the efficacy of the novel bag mask ventilation augmentation technique of placing a large perforated Tegaderm® over the mouth of bearded male patients in order to improve seal after induction of general anesthesia. The perforation is a diamond-shaped hole to be aligned with the patient's mouth. Patients will either start with Tegaderm application or without Tegaderm, and will then cross over to the other condition in order to be their own controls. The primary endpoint is to measure inspiratory and expiratory tidal volumes.
If shown efficacious this intervention would be an easy and cost-effective intervention to improve bag mask ventilation for bearded patients in the operating room and non-operating room environments alike.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adult patients with perioral facial hair >5mm in length
- •Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction
排除标准
- •Known allergy to Tegaderm product and/or its adhesive
- •Emergency surgery
- •Active or unstable cardiac disease
- •ASA (American Society of Anesthesiologists) physical status ≥4
- •External or internal active airway obstruction from tumor, abscess, or laryngeal edema
- •Organic or non-organic oropharyngeal anatomical defects including history of radiation treatment to the neck
- •Moderate to severe acute and chronic restrictive or obstructive lung diseases, e.g. chronic obstructive pulmonary disease, asthma, etc.
- •Requirement for rapid sequence intubation, or known aspiration risk
- •Cervical spine injury
- •Previously documented difficult mask ventilation or intubation
- •Vulnerable populations: children, prisoners, pregnant patients, cognitively impaired adults
结局指标
主要结局
Percent Air Leakage During Bag-mask Ventilation
时间窗: <5 minutes
Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.
次要结局
- Resistance(<5 minutes)
- Peak Inspiratory Pressure(<5 minutes)
研究者
Neal Gerstein
Professor
University of New Mexico