Recruiting

BCV

Sponsor:

University Medical Center of Southern Nevada

Code:

NCT03042598

Conditions

Intubation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biphasic Cuirass Ventilation

Study Details

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

Study ID

NCT03042598

Start date

Jan 14, 2017

Status verified date

Feb, 2017

Completion date

Apr, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

David E Slattery, MD

702-561-6260dslatts@me.com

Wesley J Forred, RN

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

Locations

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Wesley J Forred, RN

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

Ronald Roemer, BS

702-207-8345ronald.roemer@umcsn.com

More Information

Sponsor

University Medical Center of Southern Nevada

Last update posted

Feb 3, 2017

Last verified

Feb, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Medical Center of Southern Nevada on 2017-02-03.