Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2017-01-14
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient's primary language is English.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Medical Center of Southern Nevada
OTHER
Responsible Party
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David E Slattery
MD
Principal Investigators
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David E Slattery, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center of Southern Nevada
Locations
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University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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EM 2016.05
Identifier Type: -
Identifier Source: org_study_id
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