Biphasic Ventilation Airway Management Clinical Trial

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.

Inclusion Criteria:

- Patients who present to the adult emergency department and require emergency
intubation.

- Patient's primary language is English.

Exclusion Criteria:

- 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 40.

- History of valvular heart disease.

- Presence of subclavian central line or pacemaker which impairs ability of shell to
seal.