Biphasic Ventilation Airway Management Clinical Trial (BVAM)

University Medical Center of Southern Nevada

Status: Unknown

Conditions: Intubation

Treatments: Device: Biphasic Cuirass Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03042598

EM 2016.05

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Biphasic Cuirass Ventilation

Experimental group

Description:

Patients requiring emergent intubation in the Emergency Department will be provided ventilation during the apnic phase of intubation via the use of BCV.

Treatment:

Device: Biphasic Cuirass Ventilation