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Biphasic Ventilation Airway Management Clinical Trial (BVAM)

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ClinicalTrials.gov Identifier: NCT03042598
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
David E Slattery, University Medical Center of Southern Nevada

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

Condition or disease Intervention/treatment Phase
Intubation Device: Biphasic Cuirass Ventilation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm interventional feasibility trial to determine if the use of a Biphasic Cuirass Ventilator during the apneic period of intubation will decrease the prevalence of oxygen desaturation in patients undergoing RSI as compared to historical proportions of 20%.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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?
Actual Study Start Date : January 14, 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: Biphasic Cuirass Ventilation
Patients requiring emergent intubation in the Emergency Department will be provided ventilation during the apnic phase of intubation via the use of BCV.
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.
Other Name: RTX Respirator, Hayek Medical




Primary Outcome Measures :
  1. 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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Prevalence of post-paralytic Bag valve mask use [ Time Frame: Time from paralytics administered until proper endotracheal tube placement is confirmed. ]
    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.

  2. Waveform capnography pattern [ Time Frame: Baseline to 30 minutes after intubation ]
    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.

  3. Change in End-Tidal Carbon Dioxide (ETCO2) values [ Time Frame: Period of time from acquiring baseline ETCO2 value to successful intubation. ]
    We will describe the change in the mean +/- SEM and median +/- IQR ETCO2 values as measured from baseline to intubation.

  4. Blood Pressure response to the BCV device [ Time Frame: Baseline vital signs to 30 Minutes after intubation ]
    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

  5. SpO2 response to pre-oxygenation attempts BCV application [ Time Frame: Baseline vital signs to 30 Minutes after intubation ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042598


Contacts
Contact: David E Slattery, MD 702-561-6260 dslatts@me.com
Contact: Wesley J Forred, RN 702-466-7801 wesley.forred@umcsn.com

Locations
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Wesley J Forred, RN    702-466-7801    wesley.forred@umcsn.com   
Contact: Ronald Roemer, BS    702-207-8345    ronald.roemer@umcsn.com   
Sponsors and Collaborators
University Medical Center of Southern Nevada
Investigators
Principal Investigator: David E Slattery, MD University Medical Center of Southern Nevada

Publications:

Responsible Party: David E Slattery, MD, University Medical Center of Southern Nevada
ClinicalTrials.gov Identifier: NCT03042598     History of Changes
Other Study ID Numbers: EM 2016.05
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data (IPD) will not be shared

Keywords provided by David E Slattery, University Medical Center of Southern Nevada:
Safe Apneic Period
Emergency Intubation
Biphasic Cuirass Ventilation (BCV)
Non-invasive ventilation
Peri-intubation Hemodynamic instability
desaturation
waveform capnography
Patient safety