Clinical trial NCT03042598: Biphasic Ventilation Airway Management Clinical Trial
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Keywords: Safe Apneic Period
Emergency Intubation
Biphasic Cuirass Ventilation (BCV)
Non-invasive ventilation
Peri-intubation Hemodynamic instability
desaturation
waveform capnography
Patient safety
Lead sponsor: University Medical Center of Southern Nevada
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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

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.

Eligibility 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.

Primary outcomes:
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
timeFrame: 0 to 5 minutes after intubation
Secondary outcomes:
measure: Prevalence of post-paralytic Bag valve mask use
timeFrame: Time from paralytics administered until proper endotracheal tube placement is confirmed.
measure: Waveform capnography pattern
timeFrame: Baseline to 30 minutes after intubation
measure: Change in End-Tidal Carbon Dioxide (ETCO2) values
timeFrame: Period of time from acquiring baseline ETCO2 value to successful intubation.
measure: Blood Pressure response to the BCV device
timeFrame: Baseline vital signs to 30 Minutes after intubation
measure: SpO2 response to pre-oxygenation attempts BCV application
timeFrame: Baseline vital signs to 30 Minutes after intubation
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
Study officials:
affiliation: University Medical Center of Southern Nevada
name: David E Slattery, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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: 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: 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.