IntubationBVAMNCT03042598
Biphasic Ventilation Airway Management Clinical Trial
A study testing Biphasic Cuirass Ventilation in people with Intubation, run by University Medical Center of Southern Nevada at 1 site in United States.
Trial summary
Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves patient safety (avoiding hypoxia) during emergency rapid sequence intubation . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Biphasic Cuirass Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2017to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present to the adult emergency department and require emergency intubation.
- Patient's primary language is English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Wesley J Forred, RN, 702-466-7801, wesley.forred@umcsn.com
Ronald Roemer, BS, 702-207-8345, ronald.roemer@umcsn.com
About this study
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?
Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves patient safety (avoiding hypoxia) during emergency rapid sequence intubation .
Read the 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.
- Conditions
- Intubation
- Being tested
- Biphasic Cuirass Ventilation
- Keywords
- Safe Apneic Period, Emergency Intubation, Biphasic Cuirass Ventilation (BCV), Non-invasive ventilation, Peri-intubation Hemodynamic instability, desaturation, waveform capnography, Patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Cuirass VentilationDevice
Also called RTX Respirator, Hayek Medical
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Biphasic Cuirass Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 5 minutes after intubation
Secondary outcomes (5)
Prevalence of post-paralytic Bag valve mask use
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.
Measured: Time from paralytics administered until proper endotracheal tube placement is confirmed.
Waveform capnography pattern
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.
Measured: Baseline to 30 minutes after intubation
Change in End-Tidal Carbon Dioxide (ETCO2) values
We will describe the change in the mean +/- SEM and median +/- IQR ETCO2 values as measured from baseline to intubation.
Measured: Period of time from acquiring baseline ETCO2 value to successful intubation.
Blood Pressure response to the BCV device
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
Measured: Baseline vital signs to 30 Minutes after intubation
SpO2 response to pre-oxygenation attempts BCV application
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
Measured: Baseline vital signs to 30 Minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start14 Jan 2017
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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%.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center of Southern Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Slattery, University Medical Center of Southern Nevada
- Investigators
- David E Slattery, MD, Principal investigator, University Medical Center of Southern Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042598
- Sponsor's protocol ID
- EM 2016.05
- Acronym
- BVAM
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared
Publications
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.
PubMed 22050948Bodily 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.
PubMed 26164643Sakles 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.
PubMed 23574475Brimacombe 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.
PubMed 15629910Kamine 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.
PubMed 24522521Li 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.
PubMed 10102312Benumof 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.
PubMed 9357902Corrado 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.
PubMed 19020859
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03042598
- Acronym / sponsor ID
- BVAM / EM 2016.05
- Conditions
- Intubation
- Keywords
- Safe Apneic Period, Emergency Intubation, Biphasic Cuirass Ventilation (BCV), Non-invasive ventilation, Peri-intubation Hemodynamic instability, desaturation, waveform capnography, Patient safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Medical Center of Southern NevadaUniversity, hospital or other
- Study start
- 14 Jan 2017 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Biphasic Cuirass Ventilation | Experimental | Device: Biphasic Cuirass VentilationPatients requiring emergent intubation in the Emergency Department will be provided ventilation during the apnic phase of intubation via the use of BCV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who present to the adult emergency department and require emergency intubation.
- Patient's primary language is English.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biphasic Cuirass VentilationAlso: RTX Respirator, Hayek MedicalThe 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. | Device | Biphasic Cuirass Ventilation |
Primary outcome
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
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.
5 secondary outcomes
Prevalence of post-paralytic Bag valve mask use
Time frame: Time from paralytics administered until proper endotracheal tube placement is confirmed.
Waveform capnography pattern
Time frame: Baseline to 30 minutes after intubation
Change in End-Tidal Carbon Dioxide (ETCO2) values
Time frame: Period of time from acquiring baseline ETCO2 value to successful intubation.
Blood Pressure response to the BCV device
Time frame: Baseline vital signs to 30 Minutes after intubation
SpO2 response to pre-oxygenation attempts BCV application
Time frame: Baseline vital signs to 30 Minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 22050948Weingart 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.
- Background: PubMed 26164643Bodily 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.
- Background: PubMed 23574475Sakles 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.
- Background: PubMed 15629910Brimacombe 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.
- Background: PubMed 24522521Kamine 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.
- Background: PubMed 10102312Li 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.
- Background: PubMed 9357902Benumof 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.
- Background: PubMed 19020859Corrado 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.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Slattery, MD principal investigator
University Medical Center of Southern Nevada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic Cuirass Ventilation in people with Intubation, run by University Medical Center of Southern Nevada at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David E Slattery, MD (702-561-6260, dslatts@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042598, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.