Biphasic Ventilation Airway Management Clinical Trial

NCT03042598 | Unknown DMC

• 1 other identifier: EM 2016.05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation

Keywords

Safe Apneic Period; Emergency Intubation; Biphasic Cuirass Ventilation (BCV); Non-invasive ventilation; Peri-intubation Hemodynamic instability; desaturation; waveform capnography; Patient safety

Outcome Measures

Primary Outcomes (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

  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 Outcomes (5)

• Prevalence of post-paralytic Bag valve mask use

  Time from paralytics administered until proper endotracheal tube placement is confirmed.

• Waveform capnography pattern

  Baseline to 30 minutes after intubation

• Change in End-Tidal Carbon Dioxide (ETCO2) values

  Period of time from acquiring baseline ETCO2 value to successful intubation.

• Blood Pressure response to the BCV device

  Baseline vital signs to 30 Minutes after intubation

• SpO2 response to pre-oxygenation attempts BCV application

  Baseline vital signs to 30 Minutes after intubation

Study Arms (1)

Biphasic Cuirass Ventilation

EXPERIMENTAL

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

Interventions

Biphasic Cuirass Ventilation DEVICE

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.

Also known as: RTX Respirator, Hayek Medical

Biphasic Cuirass Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present to the adult emergency department and require emergency intubation.
• Patient's primary language is English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center of Southern Nevada: lead

Study Sites (1)

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• David E Slattery, MD

  University Medical Center of Southern Nevada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David E Slattery, MD

CONTACT

702-561-6260; dslatts@me.com

Wesley J Forred, RN

CONTACT

702-466-7801; wesley.forred@umcsn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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%.

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: February 3, 2017
• Study Start: January 14, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)