Intubation Clinical Trial
— BVAMOfficial title:
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?
Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves patient safety (avoiding hypoxia) during emergency rapid sequence intubation .
Status | Recruiting |
Enrollment | 15 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
University Medical Center of Southern Nevada |
United States,
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Bodily JB, Webb HR, Weiss SJ, Braude DA. Incidence and Duration of Continuously Measured Oxygen Desaturation During Emergency Department Intubation. Ann Emerg Med. 2016 Mar;67(3):389-95. doi: 10.1016/j.annemergmed.2015.06.006. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 0 to 5 minutes after intubation | |
Secondary | Prevalence of post-paralytic Bag valve mask use | Prevalence of post-paralytic administration bag valve mask ventilation in subjects enrolled into trial. We will describe this with a percentage and surrounding 95% confidence interval. This outcome reflects the potential need for ventilation during and around the intubation attempt. Our hypothesis is that BCV will eliminate the physiologic need for BVM rescue ventilation between the time paralytics are administered until the endotracheal tube is confirmed to be properly placed. | Time from paralytics administered until proper endotracheal tube placement is confirmed. | |
Secondary | Waveform capnography pattern | The investigators will describe the pattern of waveform capnography as measured by the research nasal capnography monitor. The waveform capnography trends will be represented graphically as continuous data for each subject over time to reflect the patterns observed from baseline until endotracheal tube is successfully placed in the trachea. | Baseline to 30 minutes after intubation | |
Secondary | Change in End-Tidal Carbon Dioxide (ETCO2) values | We will describe the change in the mean +/- SEM and median +/- IQR ETCO2 values as measured from baseline to intubation. | Period of time from acquiring baseline ETCO2 value to successful intubation. | |
Secondary | Blood Pressure response to the BCV device | Investigators will describe the physiologic response to the BCV device by graphically representing each subject's systolic, diastolic, and mean arterial pressures (mmHG) in serial 5 minute measurements obtained from the immediate pre-application of the BCV device period until 30 minutes after intubation is complete. Unit of measure= mmHG | Baseline vital signs to 30 Minutes after intubation | |
Secondary | SpO2 response to pre-oxygenation attempts BCV application | Investigators will describe the physiologic response to the BCV device by graphically representing each subject's oxygen saturation measurements obtained from the immediate pre-application of the BCV device period until 30 minutes after intubation is complete. Unit of measure= % oxygen saturation | Baseline vital signs to 30 Minutes after intubation |
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