A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- End-tidal oxygen concentration
研究概览
简要总结
This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status class 1-2
- •Undergoing elective surgery
- •Aged between 18 and 75 years
排除标准
- •Severe acute or chronic lung disease requiring oxygen-therapy;
- •Hiatus hernia with gastro-esophageal reflux or other esophageal or gastric abnormalities that require a rapid sequence induction;
- •Food intake within the last 6 hours or clear fluid intake within 2 hours prior to surgery;
- •Ischemic or congenital heart disease;
- •Pregnancy (confirmed by a pregnancy test);
- •Patient is scheduled for regional anesthesia and denies conductance of general anesthesia during the surgical procedure;
- •Known difficult intubation in the past.
- •Difficult Mask Ventilation. Patients having any two of the criteria listed below will be Categorized as "Difficult Mask Ventilation (DMV)" (5,13,14) and will be excluded from enrollment. All others will be classified as "Normal." Age > 55 BMI > 26 kg/m2 Lack of teeth Presence of beard History of snoring Limited mandibular protrusion
研究组 & 干预措施
EcoAnesthesia Mask first
Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. This group will receive the EcoAnesthesia Mask first.
干预措施: Portex Adult (Standard) facemask second (Device)
EcoAnesthesia Mask first
Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. This group will receive the EcoAnesthesia Mask first.
干预措施: EcoAnaesthesia facemask first (Device)
Standard mask first
Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. Patients in this arm will receive the standard mask first.
干预措施: Portex Adult (Standard) facemask first (Device)
Standard mask first
Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. Patients in this arm will receive the standard mask first.
干预措施: EcoAnesthesia facemask second (Device)
结局指标
主要结局
End-tidal oxygen concentration
时间窗: three minutes
End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.
次要结局
- Maximum airway pressure(End of 3 minutes with each mask)