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临床试验/NCT02580526
NCT02580526已完成不适用

Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

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:

  1. Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
  2. 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

Active Comparator

干预措施: C-E mask ventilation for one minute (Procedure)

V-E mask ventilation technique crossover C-E mask ventilation

Active Comparator

干预措施: V-E mask ventilation for one minute (Procedure)

C-E mask ventilation technique crossover V-E mask ventilation

Active Comparator

干预措施: V-E mask ventilation for one minute (Procedure)

C-E mask ventilation technique crossover V-E mask ventilation

Active Comparator

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

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

Yandong Jiang

Professor Department of Anesthesiology

Vanderbilt University Medical Center

研究点 (1)

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