Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 2
- 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 in 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 non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.
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 bag valve mask (i.e. 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 non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
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 at Rhode Island Hospital.
- •American Society of Anesthesiologists physical status 1 and 2
排除标准
- •ASA PS >3 (e.g., respiratory disease)
- •Oropharyngeal or facial pathology
结局指标
主要结局
Peak airway pressure
时间窗: Recorded for 3 minute duration for each arm of the study
mean peak airway pressure expressed in cm H20
次要结局
- Respiratory rate(Recorded for 3 minute duration for each arm of the study)
- Oxygen saturation (SpO2)(Recorded for 3 minute duration for each arm of the study)
- Heart rate(Recorded for 3 minute duration for each arm of the study)
- Airflow(Recorded for 3 minute duration for each arm of the study)
- Tidal volume(Recorded for 3 minute duration for each arm of the study)
- End Tidal CO2(Recorded for 3 minute duration for each arm of the study)
- Blood pressure(Recorded for 3 minute duration for each arm of the study)
研究者
Mark Kendall
Director of Clinical Research
Rhode Island Hospital