NCT03042598

Biphasic Ventilation Airway Management Clinical Trial

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?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Medical Center of Southern Nevada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves patient safety (avoiding hypoxia) during emergency rapid sequence intubation .

Detailed description

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.

Conditions

• Intubation

Interventions

Type	Name	Description
DEVICE	Biphasic Cuirass Ventilation	The RTX Respirator will be applied to the patient's chest to provide non-invasive ventilatory support using a Biphasic Cuirass Ventilation technology to increase the safe apnic period during intubation.

Timeline

• Start date: 2017-01-14
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2017-02-03
• Last updated: 2017-02-03

Locations

1 site across 1 country: United States