Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Difference in expired tidal volume for one minute of each technique
研究概览
简要总结
This study compares the effectiveness of two kinds of two-handed facemask ventilation techniques (when breathing is supported with machines) at the time that general anesthesia is started. Study participants will start with one technique and then cross over to the other technique.
详细描述
This study will compare the effectiveness of two-handed V-E mask ventilation technique with the C-E technique. The study hypothesis is based on following considerations:
- Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
- V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region.
Anesthesia care team members, residents or CRNAs familiar with bag-valve mask ventilation, will perform mask ventilation. After receiving preoperative medications, subjects will be placed on the operating table, and electrocardiogram, noninvasive blood pressure, and cutaneous oxyhemoglobin saturation monitoring will be applied. The depth of sedation will be assessed and kept by the care team with IV bolus of propofol.
The sizes of masks will be chosen by the care team and only one size will be used for both techniques. The subject's head will be placed in the neutral position on a pillow and elevate 10 cm from the operating room table, but no backward head tilt or jaw thrust will be performed. One hundred percent oxygen will be delivered throughout the study. The subject will be encouraged to hyperventilate by taking deep breaths to facilitate preoxygenation before the induction of anesthesia.
Pre-oxygenation will be carried out with maximal fresh gas flow and FiO2 1.0 until the expired O2 at or greater than 80%. Then anesthesia will be induced by an intravenous bolus injection of propofol (1-2 mg/kg) after an intravenous bolus injection of fentanyl (50-150 ug).
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
- •>18 years of age
- •Requiring general anesthesia in the main operating rooms at Vanderbilt University Medical Center
- •BMI greater than 30
排除标准
- •Untreated ischemic heart diseases
- •Respiratory disorders, including COPD and asthma,
- •American Society of Anesthesiologists (ASA) physical class of 4 or greater,
- •Undergoing emergency surgery,
- •Requiring rapid sequence intubation for aspiration protection,
- •Induction of anesthesia is not done with IV propofol,
- •Requiring fiberoscopic intubation.
研究组 & 干预措施
V-E mask ventilation technique crossover C-E mask ventilation
干预措施: C-E mask ventilation for one minute (Procedure)
V-E mask ventilation technique crossover C-E mask ventilation
干预措施: V-E mask ventilation for one minute (Procedure)
C-E mask ventilation technique crossover V-E mask ventilation
干预措施: V-E mask ventilation for one minute (Procedure)
C-E mask ventilation technique crossover V-E mask ventilation
干预措施: C-E mask ventilation for one minute (Procedure)
结局指标
主要结局
Difference in expired tidal volume for one minute of each technique
时间窗: one minute of expired tidal volume for each mask ventilation technique
次要结局
未报告次要终点
研究者
Yandong Jiang
Professor Department of Anesthesiology
Vanderbilt University Medical Center
