Is Biphasic Ventilation Airway Management Utilizing Biphasic Cuirass Ventilation a Feasible Method to Provide Ventilation During the Apneic Phase for Patients Undergoing Emergent Rapid Sequence Intubation in the Emergency Department?
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Composite Primary Endpoint is the composite prevalence of any desaturation defined as SPO2 < 95% or Bradycardia, HR <60 beats per minute sustained for at least 30 seconds
研究概览
简要总结
Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves patient safety (avoiding hypoxia) during emergency rapid sequence intubation .
详细描述
Methods/ Interventions:
Patients who are deemed to meet inclusion criteria and none of the exclusion criteria will be preoxygenated by any of the acceptable standard preoxygenation strategies (non-rebreather face mask, noninvasive positive pressure ventilation, etc.) . Patients will be placed and maintained on continuous 3-lead cardiac, automatic blood pressure, pulse oximeter, and waveform capnography monitoring for the duration of the procedure. Prior to induction, and during the pre oxygenation phase, subjects will be placed on the Biphasic Cuirass Ventilation (BCV) device per the manufacturer's guidelines. After adequate preoxygenation has been achieved (as determined by the treating emergency physician), the BCV assisted ventilations will be maintained and standard of care intubation procedures including apenic oxygenation if ordered by attending emergency physician will be utilized. BCV will be discontinued upon confirmation of proper tracheal intubation by waveform capnography.
Safety The BCV device covers the anterior chest wall, and therefore, it cannot be in place if CPR is needed. Therefore, all patients in cardiac arrest will be excluded. Investigators will be excluding patients with a pacemaker or central line which impairs the ability of the Curiass shell to secure on the anterior chest. Finally, patients with a history of valvular heart disease will be excluded. The protocol directs the device be applied during the normal preoxygenation period (~within that 3-5 minute period of time prior to the administration of the induction and paralytic medications). There are no other known side effects of this device. There is a potential for the device application to delay the intubation attempt; however, it is not known whether delaying intubation ,while augmenting a patient's breathing with the BCV device, negatively impacts the patient's condition. The data collection form explicitly asks the intubating physician thinks that the device delayed the intubation attempt in any way. The data collection form also tracks all of the relevant time milestones. Both of these items will be reviewed periodically during the study as safety endpoints by the data monitoring committee and will be included in the manuscript results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients who present to the adult emergency department and require emergency intubation.
- •Patient's primary language is English.
排除标准
- •Cardiac arrest.
- •Attending provider excludes patient as being at high risk for cardiac arrest or for any other reason.
- •Patients who are known or reported to be pregnant pre-procedure.
- •Patients in the custody of law enforcement.
- •Inability to pre-oxygenate patient to an SPO2 equal to or greater than 95 percent prior to induction.
- •Morbidly or Extremely obese patients defined by the NIH as BMI greater than
- •History of valvular heart disease.
- •Presence of subclavian central line or pacemaker which impairs ability of shell to seal.
结局指标
主要结局
Composite Primary Endpoint is the composite prevalence of any desaturation defined as SPO2 < 95% or Bradycardia, HR <60 beats per minute sustained for at least 30 seconds
时间窗: 0 to 5 minutes after intubation
The primary outcome measure is the composite prevalence of any desaturation defined as SPO2 \< 95% or Bradycardia, HR \<60 beats per minute sustained for at least 30 seconds, during and in the immediate post intubation (5 minutes after tracheal intubation is confirmed) period.
次要结局
- Prevalence of post-paralytic Bag valve mask use(Time from paralytics administered until proper endotracheal tube placement is confirmed.)
- Waveform capnography pattern(Baseline to 30 minutes after intubation)
- Change in End-Tidal Carbon Dioxide (ETCO2) values(Period of time from acquiring baseline ETCO2 value to successful intubation.)
- Blood Pressure response to the BCV device(Baseline vital signs to 30 Minutes after intubation)
- SpO2 response to pre-oxygenation attempts BCV application(Baseline vital signs to 30 Minutes after intubation)
研究者
David E Slattery
MD
University Medical Center of Southern Nevada
