<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042598</url>
  </required_header>
  <id_info>
    <org_study_id>EM 2016.05</org_study_id>
    <nct_id>NCT03042598</nct_id>
  </id_info>
  <brief_title>Biphasic Ventilation Airway Management Clinical Trial</brief_title>
  <acronym>BVAM</acronym>
  <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?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center of Southern Nevada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center of Southern Nevada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves&#xD;
      patient safety (avoiding hypoxia) during emergency rapid sequence intubation .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods/ Interventions:&#xD;
&#xD;
      Patients who are deemed to meet inclusion criteria and none of the exclusion criteria will be&#xD;
      preoxygenated by any of the acceptable standard preoxygenation strategies (non-rebreather&#xD;
      face mask, noninvasive positive pressure ventilation, etc.) . Patients will be placed and&#xD;
      maintained on continuous 3-lead cardiac, automatic blood pressure, pulse oximeter, and&#xD;
      waveform capnography monitoring for the duration of the procedure. Prior to induction, and&#xD;
      during the pre oxygenation phase, subjects will be placed on the Biphasic Cuirass Ventilation&#xD;
      (BCV) device per the manufacturer's guidelines. After adequate preoxygenation has been&#xD;
      achieved (as determined by the treating emergency physician), the BCV assisted ventilations&#xD;
      will be maintained and standard of care intubation procedures including apenic oxygenation if&#xD;
      ordered by attending emergency physician will be utilized. BCV will be discontinued upon&#xD;
      confirmation of proper tracheal intubation by waveform capnography.&#xD;
&#xD;
      Safety The BCV device covers the anterior chest wall, and therefore, it cannot be in place if&#xD;
      CPR is needed. Therefore, all patients in cardiac arrest will be excluded. Investigators will&#xD;
      be excluding patients with a pacemaker or central line which impairs the ability of the&#xD;
      Curiass shell to secure on the anterior chest. Finally, patients with a history of valvular&#xD;
      heart disease will be excluded. The protocol directs the device be applied during the normal&#xD;
      preoxygenation period (~within that 3-5 minute period of time prior to the administration of&#xD;
      the induction and paralytic medications). There are no other known side effects of this&#xD;
      device. There is a potential for the device application to delay the intubation attempt;&#xD;
      however, it is not known whether delaying intubation ,while augmenting a patient's breathing&#xD;
      with the BCV device, negatively impacts the patient's condition. The data collection form&#xD;
      explicitly asks the intubating physician thinks that the device delayed the intubation&#xD;
      attempt in any way. The data collection form also tracks all of the relevant time milestones.&#xD;
      Both of these items will be reviewed periodically during the study as safety endpoints by the&#xD;
      data monitoring committee and will be included in the manuscript results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2017</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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%.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Primary Endpoint is the composite prevalence of any desaturation defined as SPO2 &lt; 95% or Bradycardia, HR &lt;60 beats per minute sustained for at least 30 seconds</measure>
    <time_frame>0 to 5 minutes after intubation</time_frame>
    <description>The primary outcome measure is the composite prevalence of any desaturation defined as SPO2 &lt; 95% or Bradycardia, HR &lt;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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of post-paralytic Bag valve mask use</measure>
    <time_frame>Time from paralytics administered until proper endotracheal tube placement is confirmed.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waveform capnography pattern</measure>
    <time_frame>Baseline to 30 minutes after intubation</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in End-Tidal Carbon Dioxide (ETCO2) values</measure>
    <time_frame>Period of time from acquiring baseline ETCO2 value to successful intubation.</time_frame>
    <description>We will describe the change in the mean +/- SEM and median +/- IQR ETCO2 values as measured from baseline to intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure response to the BCV device</measure>
    <time_frame>Baseline vital signs to 30 Minutes after intubation</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2 response to pre-oxygenation attempts BCV application</measure>
    <time_frame>Baseline vital signs to 30 Minutes after intubation</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>Biphasic Cuirass Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients requiring emergent intubation in the Emergency Department will be provided ventilation during the apnic phase of intubation via the use of BCV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biphasic Cuirass Ventilation</intervention_name>
    <description>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.</description>
    <arm_group_label>Biphasic Cuirass Ventilation</arm_group_label>
    <other_name>RTX Respirator, Hayek Medical</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present to the adult emergency department and require emergency&#xD;
             intubation.&#xD;
&#xD;
          -  Patient's primary language is English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrest.&#xD;
&#xD;
          -  Attending provider excludes patient as being at high risk for cardiac arrest or for&#xD;
             any other reason.&#xD;
&#xD;
          -  Patients who are known or reported to be pregnant pre-procedure.&#xD;
&#xD;
          -  Patients in the custody of law enforcement.&#xD;
&#xD;
          -  Inability to pre-oxygenate patient to an SPO2 equal to or greater than 95 percent&#xD;
             prior to induction.&#xD;
&#xD;
          -  Morbidly or Extremely obese patients defined by the NIH as BMI greater than 40.&#xD;
&#xD;
          -  History of valvular heart disease.&#xD;
&#xD;
          -  Presence of subclavian central line or pacemaker which impairs ability of shell to&#xD;
             seal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David E Slattery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center of Southern Nevada</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David E Slattery, MD</last_name>
    <phone>702-561-6260</phone>
    <email>dslatts@me.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wesley J Forred, RN</last_name>
    <phone>702-466-7801</phone>
    <email>wesley.forred@umcsn.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wesley J Forred, RN</last_name>
      <phone>702-466-7801</phone>
      <email>wesley.forred@umcsn.com</email>
    </contact>
    <contact_backup>
      <last_name>Ronald Roemer, BS</last_name>
      <phone>702-207-8345</phone>
      <email>ronald.roemer@umcsn.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.</citation>
    <PMID>22050948</PMID>
  </reference>
  <reference>
    <citation>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. Epub 2015 Jul 9.</citation>
    <PMID>26164643</PMID>
  </reference>
  <reference>
    <citation>Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.</citation>
    <PMID>23574475</PMID>
  </reference>
  <reference>
    <citation>Brimacombe J, Keller C. Who is at increased risk of aspiration? Br J Anaesth. 2005 Feb;94(2):251; author reply 251-2. doi: 10.1093/bja/aei511. No abstract available.</citation>
    <PMID>15629910</PMID>
  </reference>
  <reference>
    <citation>Kamine TH, Papavassiliou E, Schneider BE. Effect of abdominal insufflation for laparoscopy on intracranial pressure. JAMA Surg. 2014 Apr;149(4):380-2. doi: 10.1001/jamasurg.2013.3024.</citation>
    <PMID>24522521</PMID>
  </reference>
  <reference>
    <citation>Li J, Murphy-Lavoie H, Bugas C, Martinez J, Preston C. Complications of emergency intubation with and without paralysis. Am J Emerg Med. 1999 Mar;17(2):141-3. doi: 10.1016/s0735-6757(99)90046-3.</citation>
    <PMID>10102312</PMID>
  </reference>
  <reference>
    <citation>Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to an unparalyzed state following 1 mg/kg intravenous succinylcholine. Anesthesiology. 1997 Oct;87(4):979-82. doi: 10.1097/00000542-199710000-00034. No abstract available.</citation>
    <PMID>9357902</PMID>
  </reference>
  <reference>
    <citation>Corrado A, Gorini M, Melej R, Baglioni S, Mollica C, Villella G, Consigli GF, Dottorini M, Bigioni D, Toschi M, Eslami A. Iron lung versus mask ventilation in acute exacerbation of COPD: a randomised crossover study. Intensive Care Med. 2009 Apr;35(4):648-55. doi: 10.1007/s00134-008-1352-9. Epub 2008 Nov 20.</citation>
    <PMID>19020859</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center of Southern Nevada</investigator_affiliation>
    <investigator_full_name>David E Slattery</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Safe Apneic Period</keyword>
  <keyword>Emergency Intubation</keyword>
  <keyword>Biphasic Cuirass Ventilation (BCV)</keyword>
  <keyword>Non-invasive ventilation</keyword>
  <keyword>Peri-intubation Hemodynamic instability</keyword>
  <keyword>desaturation</keyword>
  <keyword>waveform capnography</keyword>
  <keyword>Patient safety</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data (IPD) will not be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042598
org study id: EM 2016.05
nct id: NCT03042598
lead sponsor: 
has dmc: Yes
Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves
      patient safety (avoiding hypoxia) during emergency rapid sequence intubation .
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.
allocation: N/A
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%.
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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
description: 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.
measure: Prevalence of post-paralytic Bag valve mask use
time frame: Time from paralytics administered until proper endotracheal tube placement is confirmed.
description: 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.
measure: Waveform capnography pattern
time frame: Baseline to 30 minutes after intubation
description: 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.
measure: Change in End-Tidal Carbon Dioxide (ETCO2) values
time frame: Period of time from acquiring baseline ETCO2 value to successful intubation.
description: We will describe the change in the mean +/- SEM and median +/- IQR ETCO2 values as measured from baseline to intubation.
measure: Blood Pressure response to the BCV device
time frame: Baseline vital signs to 30 Minutes after intubation
description: 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
measure: SpO2 response to pre-oxygenation attempts BCV application
time frame: Baseline vital signs to 30 Minutes after intubation
description: 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
arm group label: Biphasic Cuirass Ventilation
arm group type: Experimental
description: Patients requiring emergent intubation in the Emergency Department will be provided ventilation during the apnic phase of intubation via the use of BCV.
intervention type: Device
intervention name: Biphasic Cuirass Ventilation
description: 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.
arm group label: Biphasic Cuirass Ventilation
other name: RTX Respirator, Hayek Medical
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David E Slattery, MD
role: Principal Investigator
affiliation: University Medical Center of Southern Nevada
last name: David E Slattery, MD
phone: 702-561-6260
email: dslatts@me.com
last name: Wesley J Forred, RN
phone: 702-466-7801
email: wesley.forred@umcsn.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PMID: 22050948
citation: 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. Epub 2015 Jul 9.
PMID: 26164643
citation: Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
PMID: 23574475
citation: Brimacombe J, Keller C. Who is at increased risk of aspiration? Br J Anaesth. 2005 Feb;94(2):251; author reply 251-2. doi: 10.1093/bja/aei511. No abstract available.
PMID: 15629910
citation: Kamine TH, Papavassiliou E, Schneider BE. Effect of abdominal insufflation for laparoscopy on intracranial pressure. JAMA Surg. 2014 Apr;149(4):380-2. doi: 10.1001/jamasurg.2013.3024.
PMID: 24522521
citation: Li J, Murphy-Lavoie H, Bugas C, Martinez J, Preston C. Complications of emergency intubation with and without paralysis. Am J Emerg Med. 1999 Mar;17(2):141-3. doi: 10.1016/s0735-6757(99)90046-3.
PMID: 10102312
citation: Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to an unparalyzed state following 1 mg/kg intravenous succinylcholine. Anesthesiology. 1997 Oct;87(4):979-82. doi: 10.1097/00000542-199710000-00034. No abstract available.
PMID: 9357902
citation: Corrado A, Gorini M, Melej R, Baglioni S, Mollica C, Villella G, Consigli GF, Dottorini M, Bigioni D, Toschi M, Eslami A. Iron lung versus mask ventilation in acute exacerbation of COPD: a randomised crossover study. Intensive Care Med. 2009 Apr;35(4):648-55. doi: 10.1007/s00134-008-1352-9. Epub 2008 Nov 20.
PMID: 19020859
responsible party type: Principal Investigator
investigator affiliation: University Medical Center of Southern Nevada
investigator full name: David E Slattery
investigator title: MD
sharing ipd: No
ipd description: Individual Participant Data (IPD) will not be shared