A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peak airway pressure
研究概览
简要总结
Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.
详细描述
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a manual resuscitator and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study (margin 7.5 cm H20), the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The care provider will not know the recorded lung function recordings.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
- •American Society Of Anesthesiologists Physical Status 1 and 2
排除标准
- •American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
- •Oropharyngeal or facial pathology
研究组 & 干预措施
Bag mask ventilation with Adult Sotair device
The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.
干预措施: Adult Sotair Device (Device)
Bag mask ventilation
The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.
结局指标
主要结局
Peak airway pressure
时间窗: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Mean of the maximum peak airway pressures expressed in cm H2O
次要结局
- Airflow(Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study)
- Tidal volume(Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study)
研究者
Mark Kendall
Director of Clinical Research
Rhode Island Hospital