Invasive Bi-level Positive Airway Pressure (BiPAP): An ...

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April 29, 2020 Invasive Bi-level Positive Airway Pressure (BiPAP): An Innovative Alternative to Ventilatory Management for COVID-19 Patients Keith Robinson, MD, MS, FCCP Pulmonary and Critical Care Medicine, Syneos Health Hugh Cassiere, MD, FCCP, FACP Chief, Critical Care Medicine North Shore University Hospital, Northwell Health Jhaymie Cappiello, MS RRT-ACCS RCP Educator-Respiratory Care Services Duke University Hospital Prepared for

Transcript of Invasive Bi-level Positive Airway Pressure (BiPAP): An ...

April 29, 2020

Invasive Bi-level Positive Airway Pressure (BiPAP):

An Innovative Alternative to Ventilatory

Management for COVID-19 Patients

Keith Robinson, MD, MS, FCCP

Pulmonary and Critical Care Medicine, Syneos Health

Hugh Cassiere, MD, FCCP, FACP

Chief, Critical Care Medicine

North Shore University Hospital, Northwell Health

Jhaymie Cappiello, MS RRT-ACCS RCP

Educator-Respiratory Care Services

Duke University Hospital

Prepared

for

2© 2020 All rights reserved | Confidential | For Syneos Health® use only

Faculty

Keith Robinson, MD, MS, FCCPPulmonary and Critical Care Medicine

Syneos Health

Hugh Cassiere, MD, FCCP, FACPChief, Critical Care Medicine

North Shore University Hospital

Northwell Health

Jhaymie Cappiello, MS RRT-ACCS RCPEducator-Respiratory Care Services

Duke University Hospital

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Audience response

Which of the following devices can be adapted to meet

the need for emergency invasive ventilation?1

Hospital BiPAP

Home-use BiPAP

CPAP

Reference: 1. Branson RC, Hess DR, Kallet R, et al. American Association for Respiratory Care: SARS-CoV-2 Guidance Document. American Association for Respiratory

Care, 9425 N. MacArthur Blvd., Ste 100, Irving TX 75063 T: 972.243.2272 W: www.aarc.org. Accessed April 19, 2020.

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Pulmonary features of COVID-19 associated ARDS

• COVID-19 associated acute respiratory distress syndrome (ARDS) is hypoxic respiratory failure that

results from inflammatory pulmonary responses to the SARS-CoV-2 virus1

– inflamed, dysfunctional alveolar epithelium

– impaired surfactant function

– reduced alveolar fluid clearance; alveoli collapse or fill, resulting in ventilation/perfusion (V/Q) mismatch

• Patients show varying degrees of hypoxemia1

• Unlike typical ARDS, however, respiratory system compliance is often near normal2

References: 1. Luks AM, Freer L, Grissom CK, et al. High Alt Med Biol. 2020 Apr 13. 2. Gattinoni L, Coppola S, Cressoni M, et al. AJRCCM Articles in Press. Published March 30, 2020.

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Formal guidelines for ARDS careStandard of ARDS care is a low tidal volume (TV) strategy on ventilator support (6 cc/kg ideal weight)1

Reference: 1. Papazian L, Aubron C, Brochard L, et al. Formal guidelines: management of acute respiratory distress syndrome. Ann. Intensive Care 9, 69 (2019). https://doi.org/10.1186/s13613-019-0540-9.

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COVID-19 caseloads are growing

• CDC estimates as many as 160 to 214 million

persons in the US could become infected,

resulting in more than 2.4 million hospitalizations1

• An estimated 1% of those infected by the SARS-

CoV-2 virus will require ventilatory support2

• Many countries, including the US, anticipate or

currently experience critical shortages of

mechanical ventilators

• Only an estimated 62,000 full-featured ventilators

and approximately 99,000 older ventilators exist in

US hospitals nationwide3

A global need: emergency sources of ventilation appropriate for the COVID-19 lung

References: 1. Fink S. Worst-case estimates for US coronavirus deaths. New York Times. March 13, 2020. https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html. Accessed online 04/18/2020.

2. Ramsey L. Business Insider. https://www.businessinsider.com/presentation-us-hospitals-preparing-for-millions-of-hospitalizations-2020-3. March 6, 2020. 3. Rubinson L, Vaughn F, Nelson S, et al. Mechanical

ventilators in US acute care hospitals. Disaster Med Public Health Prep. 2010 Oct;4(3):199-206.

COVID-19 CASELOADS

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• Bi-level Positive Airway Pressure (BiPAP) machines

are widely available hospital and at-home devices

providing bi-level positive airway pressure

• Use of BiPAP on an emergency basis for ventilation

in appropriate COVID-19 patients may conserve

ICU beds and delay or reduce the hospital’s need

for mechanical ventilation equipment

– Can meet need for low tidal volume ventilation

– Caution: using BiPAP without intubation may disperse

aerosolized virus into the treatment environment

An emergency solution: adapt BiPAP for invasive use to delay or remove need for mechanical ventilation

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• Adaptors, filters, and use of appropriate device settings

can enable BiPAP to be used with endotracheal tubes

– The U.S. Food and Drug Administration is temporarily waiving

objections to such device modifications when they do not

create an undue risk1

• Among hospitals adapting BiPAP devices for use in

COVID-19 are:

– Northwell Health, NY

– Massachusetts General Hospital, MA

– Emory Health, GA

– Broward Health Medical, FL

• Do not confuse with CPAP devices for obstructive sleep

apnea, which cannot be used for ventilation and provide

no ventilatory support

What is invasive BiPAP?

CPAP BiPAP

References: 1. U.S. Food and Drug Administration. Enforcement policy for ventilators and accessories and other respiratory devices during the coronavirus disease 2019 (COVID-19) public health emergency:

guidance for industry and Food and Drug Administration Staff. March 2020. www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-

respiratory-devices-during-coronavirus. Accessed March 20, 2020.

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• Non-invasive ventilation (NIV) should only be used in

selected patients with hypoxemic respiratory failure1

• Patients treated with either high-flow nasal oxygen or NIV

should be closely monitored for clinical deterioration1

• Clinicians may consider use of helmet interface or face

mask with BiPAP to support respiratory status1

• Risks include delayed intubation, large tidal volumes, and

injurious transpulmonary pressures1

• To reduce risk to healthcare providers:

– Use local best practices for non-invasive ventilation

– Bag valve masks (BVMs) and other ventilator equipment

should be equipped with HEPA filtration to filter expired air and

minimize aerosolization2

• If the patient isn’t stabilized in a monitored setting within 60

minutes after non-invasive BiPAP, clinicians may elect to

intubate1 and continue use with the BiPAP machine

• This can provide a means to ventilate/oxygenate patients

until a standard ventilator and ICU bed become available,

or in lieu of these resources

if they are not available

Non-invasive or invasive: which BiPAP modality to use?

References: 1. WHO Interim Guidance. Reference number: WHO/2019-nCoV/Clinical/2020.4

2. Centers for Disease Control and Prevention. www.cdc.gov/coronavirus/ 2019-ncov/hcp/guidance-for-ems.html. Accessed March 20, 2020.

Non-invasive BiPAP:

Early in the course of care

Invasive BiPAP:

If the patient isn’t stabilized quickly

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How to adapt BiPAP for invasive ventilation support*

• Replace mask with adaptor/coupler that enables

connection to endotracheal tube

• Provide humidification (active HME or with filter [HMEF])

– COVID-19 patients (especially those with underlying

respiratory conditions and/or bacterial infections) have been

reported to have difficulty adequately humidifying the airways

and patients develop tenacious, thick secretions that are

occluding their endotracheal tubes

• A leak port must be open to allow expiratory outflow

– HEPA filter on the leak port to prevent virus-containing

aerosols from contaminating room

– Contact manufacturer to obtain appropriate filter

• Program BiPAP device settings for invasive ventilation

If an HME or HMEF is used, it must be fitted between the leak

port and the endotracheal tube1 (AARC)

BiPAP

Pressure

source/controller

Single limb passive circuitLeak port

Filter

Humidifier

*Note: This is general guidance and they should contact the manufacturers for any specific modification questions as each BiPAP is likely different.

Reference: 1. American Association for Respiratory Care. Bilevel Devices Converted to Ventilators. https//www.aarc.org/clinical-resources/bilevel-devices-converted-to-ventilators/.

Accessed April 19, 2020.

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Invasive BiPAP experience has been positive in resource-poor settings or when mechanical ventilators have been unavailable

Pakistan

In comatose COPD patient responders, invasive BiPAP

significantly (P<0.01) improved coma scale scores, pH,

and PaCO21

India

In comatose COPD patient responders, invasive BiPAP

significantly improved (P≤0.001) coma scales scores, pH,

PaCO2, respiratory rate, and SOFA score2

There are reports of invasive BiPAP use in COVID-19

from Washington State, China3, Italy, France

References: 1. Akhter N, Rizvi NA. Pak J Med Sci. 2017;33(6):1444-1448. doi: https://doi.org/10.12669/pjms.336.13972. 2. Rawat J, Sindhwani G, Biswas D, et al. International Journal of COPD. 2012:7 321–325.

3. Boxue H, Lei S, Guifeng Z, et al. Poster, CHEST. October 2019, 156(4) suppl:A996. doi: https://doi.org/10.1016/j.chest.2019.08.921.

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Virus containment

considerations

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Audience response

Which of these can transmit SARS-CoV-2?1

Droplets

Aerosols

Steel

Copper

Aluminum

Wood

Paper

Glass

Latex Gloves

Reference: 1. Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and its inactivation with biocidal agents. J Hospit Infect. 2020:246-251.

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• The following aerosol-generating

procedures should be performed in Airborne

Infection Isolation Rooms1

– CPR

– Endotracheal intubation

– Non-invasive ventilation

• Aerosolized virus may leak from NIV

masks, especially if multiple mask

manipulations occur

• Personal protective equipment (PPE)

remains mandatory

Intubation may reduce aerosol leakage

Reference: 1. American Heart Association. Interim Guidance for Healthcare Providers during COVID-19 Outbreak. 2020.

https://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_505872.pdf Accessed March 29, 2020.

Aerosolized

virus leakage

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Each mask manipulation creates an aerosol risk equivalent to a one-time intubation

Risk of SARS Transmission to HCWs Exposed and Not Exposed to Aerosol-Generating Procedures, and

Aerosol Generating Procedures as Risk Factors for SARS Transmission1

References: 1. Tran K, Cimon K, Svern M, Pessoa-Silva CL, Conly J. (2012). PLoS ONE 7(4): e35797. doi:10.1371/journal.pone.0035797.

Aerosol Generating Procedures Odds ratio (95% CI)

Point estimate Pooled estimate; I2

Manipulation of oxygen mask

(2 cohort studies)

17.0 (1.8, 165.0)4.6 (0.6, 32.5); 64.8%

2.2 (0.9, 4.9)

Tracheal intubation

(4 cohort studies)

3.0 (1.4, 6.7)

6.6 (2.3, 18.9); 39.6%22.8 (3.9, 131.1)

13.8 (1.2, 161.7)

5.5 (0.6, 49.5)

Non-invasive ventilation

(2 cohort studies)2.6 (0.2, 34.5)

3.1 (1.4, 6.8); 0%3.2 (1.4, 7.2)

Mechanical ventilation

(1 cohort study)

0.9 (0.4, 2.0)N/A

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When to intubate?

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Audience response

Which of these are potential benefits of earlier intubation?

Reduces negative pressure

that could worsen pulmonary

edema and lower oxygenation

Improves patient comfort

via ventilation support

Airway protection allows

sedation and lowers

aspiration risk

Removes dead space of

trachea from ventilation and

oxygenation considerations

Avoids high risk of

NIV failure and need for

rush intubation

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Sedation may offer advantages

Sedation options:

All are available options and can be provided to a patient with airway protected

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Algorithms and device settings

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Ventilation considerations relevant to COVID-19 ARDS

In patients using excessive inspiratory effort, intubation is high priority

– Avoids excessive negative intrathoracic pressures and self-inflicted lung injury1

Reference: 1. Gattinoni L, Coppola S, Cressoni M, et al. AJRCCM Articles in Press. Published March 30, 2020 as 10.1164/rccm.202003-0817LE. 2. Siegel MD, Hyzy RC. UpToDate. November 26, 2019.

www.uptodate.com/contents/ventilator-management-strategies-for-adults-with-acute-respiratory-distress-syndrome. Accessed March 22, 2020.

PaO2

>55 mm

Hg>88% 7.35 to

7.45

SaO2 Blood pH

Treatment targets

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Mean SOFA ≤2

COVID-19 (+) or pending status

Those considered for use of NIV with face mask

Moderate ARDS (P/F ratio of 100–200)

Hemodynamically stable

Those with any chronic illness not in exacerbation during ICU stay

Which patients are candidates for emergency invasive BiPAP?

• In general, if patients have lung failure and not more than 2 organ systems in failure,

BiPAP devices may support them adequately

– Caveat: An endotracheal tube with BiPAP has not been evaluated in COVID-19 patients, nor

are there formal recommendations from critical care societies or associations

• Bedside clinicians should consider the severity of failure in multiple organs or other

symptoms of worsening ARDS

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1

Available for download at

www.covid-bipapinfo.com

Algorithms:

Smart BiPAP

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1

Available for download at

www.covid-bipapinfo.com

Algorithms:

Standard BiPAP

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THE FOLLOWING PROTOCOL HAS BEEN DEVELOPED BY NORTHWELL HEALTH FOR EMERGENCY

SITUATIONS ARISING OUT OF THE COVID-19 PUBLIC HEALTH EMERGENCY ONLY.

NORTHWELL IS SHARING THIS PROTOCOL WITH YOU, AT YOUR REQUEST, FOR INFORMATION

PURPOSES ONLY.

YOU SHOULD REVIEW AND ANALYZE THE PROTOCOL FOR YOUR OWN SPECIFIC

EMERGENCY USE PURPOSES AND MAKE YOUR OWN DETERMINATION AS TO WHETHER

AND WHEN DEPLOYMENT OF THIS PROTOCOL IS NECESSARY.

Emergency protocol for using Philips Respironics V60 ventilator with pressure control ventilation

(PCV) option as a pressure-controlled ventilator using a conventional bipap circuit

Authored by Hugh Cassiere, MD, Stanley John RT, Todd Goldstein, PhD

You may use the conventional exhalation valve and/or circuit sold by Philips Respironics

**In situations where the manufacturer’s connection is unavailable, Northwell Health has

successfully replicated and tested a 3D printed solution that is autoclavable and reusable. As the 3D

printed solution should only be used in an emergency situation, it is recommended that the bacterial

or viral filter be placed between the ET tube and the 3D printed adapter. (Photo at end of document.)

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Preliminary

results

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First experience was on

patients with non-COVID-19

respiratory failure

• Allowed us to free up FDA-

approved invasive ventilators

• Over the course of 3 weeks we

invasively ventilated 50–60 such

patients

• As of last week we continued to

ventilate 12–15 patients

Second experience was on

“surge” COVID-19 patients

• On occasion, sites were

depleted of ventilators due to

surges of COVID-19 patients

being intubated

• Providers used the protocol and

adapters were set up to rescue

these patients while awaiting

ventilator resupply

Third experience was upfront

use on COVID-19 ARDS

respiratory failure patients

• At peak of our pandemic up to

80 patients were invasively

ventilated using the V60 BiPAP

Northwell Health Experience – Philips Respironics V60 BiPAP

Started using the Philips Respironics V60 BiPAP March 2020

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Add 2 HEPA filters, one

immediately connected to the

V60 main gas port outlet and the

second HEPA gets connected to

the exhalation valve port closer

to the ET/Trach

We recommend that the HEPA

filter on the exhalation valve

port be connected to a blind

reservoir

*In order to connect to an ETT tube

you need to use the Philips

Respironics conventional exhalation

valve and/or circuit kit

28© 2020 All rights reserved | Confidential | For Syneos Health® use only

147525 v.2

Turn on machine and hit the Menu

tab. Please ensure the patient is not

connected to the V60 machine

Under the Menu tab select the

option for Mask/Port

Select →ET/Trach option

(extreme left)

Hit Accept

Then choose type of exhalation port

Select →Other

Hit Accept

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Perform exhalation port test

Keep circuit open

The machine will detect the open

circuit and ask you to occlude the

outlet port that connects to the

patient end of the circuit

Now occlude the outlet keeping the

exhalation valve port open

Hit Start Test

Test takes 4-5 seconds; when you

see the green bar the test was

completed successfully, or you

passed the test

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Select mode–Batch PCV

Place patient on the appropriate

pressure settings parameters prior

to activating mode as follows:

The EPAP will be the same as

the PEEP

For IPAP use the plateau

pressure measured on the

conventional ventilator as a

baseline

The Fi02 would be the same

The ramp should be turned off

The rise time can be adjusted

based on patients demand. We

recommend a rise time of 3

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Now activate the batch change by hitting Select (Active Batch Change)

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3D printing protocol

There are many different types of 3D

printing modalities that can be used for this

adapter. Please ensure that the STL is

printed with a biocompatible material.

*HEPA Filter placed after the adapter.

147525 v.2

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Equipment useful at bedside during invasive BiPAP

Use of BiPAP with intubation may require equipment normally used for patients on

mechanical ventilation:Suction device

to remove pulmonary secretions

Pulse oximeter

to measure saturation of oxygen in blood

BVM (often referred to as an Ambu® bag)

to provide positive pressure ventilation

Telemetry system

to measure vital signs (e.g., heart rate, breathing, blood pressure)

Capnography

to monitor CO2, if available

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Monitor:

• Tidal volume; Target tidal volume to 6 mL/kg

predicted tidal volume

• SpO2: target 88%–95%

• Arterial blood gases

• Capnography is not necessary unless needed as

a disconnect alarm

• Also important to set alarms – particularly the

disconnect alarm

• Titration

• Physical assessment – LOC

• RR comfort therapy

• Observations: accessory muscles, pulse oximetry,

HR, vitals

• Secondary driver or device back-up

• Review of analyzing blood gas (TcCO2 or EtCO2?)

• Safety considerations

• Ongoing management – potential clinical

complications (pneumothorax, gastric distention);

and potential mechanical complications

(inadequate ventilation)

Patient monitoring and intervention considerations

Reference: 1. American Association for Respiratory Care. Bilevel Devices Converted to Ventilators. https://www.aarc.org/resources/clinical-resources/bilevel-devices-converted-to-ventilators/.

Accessed April 19, 2020.

Other considerationsAARC Recommendations1

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• Prolonged stay in ICU bed shortage vs. short term

• Signs of treatment failure

• Need to prone patient due to refractory hypoxia

• Need for paralytics due to refractory hypoxia

• Multiple organs in failure

• SOFA mean score 3 or more

• Hemodynamic instability

When to progress to mechanical ventilation

ICUED to ICU

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Conclusion

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Conclusion

BiPAP machines are widely available devices providing

bi-level positive airway pressure

Use of BiPAP on an emergency basis for ventilation in appropriate

COVID-19 patients may conserve ICU beds and delay or reduce

the hospital’s need for mechanical ventilation equipment

Invasive BiPAP minimizes healthcare worker exposure to aerosols• PPE must be worn and standard precautions taken at all times

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More information about invasive BiPAP

AARC Guidance

https://www.aarc.org/wp-

content/uploads/2020/03/guidance-document-SARS-

COVID19.pdf

Additional training:

https://www.aarc.org/resources/clinical-resources/bilevel-

devices-converted-to-ventilators/

FDA Guidance

https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/enforcement-policy-ventilators-and-

accessories-and-other-respiratory-devices-during-

coronavirus

HHS Guidance

https://www.hhs.gov/sites/default/files/optimizing-

ventilator-use-during-covid19-pandemic.pdf

NIH Treatment Guidelines

https://covid19treatmentguidelines.nih.gov/critical-care/

Northwell Health

Coronavirus Digital Resource Center:

https://www.northwell.edu/coronavirus-covid-19

3D design and innovation:

https://www.northwell.edu/3d-design-innovation

Syneos Health

www.COVID-BiPAPinfo.com

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References

American Association for Respiratory Care. Bilevel Devices Converted to Ventilators.

https://www.aarc.org/resources/clinical-resources/bilevel-devices-converted-to-ventilators/.

Accessed April 19, 2020.

AHA (American Heart Association). Interim Guidance for Healthcare Providers during COVID-

19 Outbreak. 2020. https://professional.heart.org/idc/groups/ahamah-

public/@wcm/@sop/@smd/documents/downloadable/ucm_505872.pdf. Accessed March 29,

2020.

Akhter N, Rizvi NA. Application of BiPAP through Endotracheal Tube in Comatose Patients

with COPD Exacerbation. Pak J Med Sci. 2017;33(6):1444-1448. doi:

https://doi.org/10.12669/pjms.336.13972.

Aloud A. Average volume-assured pressure support. SW Respir Crit Care Chron. 2018;6:29-

37.

Boxue H, Lei S, Guifeng Z, et al. Advanced device with auto-titrating EPAP for ARDS patients.

Poster, CHEST. October 2019, 156(4) suppl:A996. doi:

https://doi.org/10.1016/j.chest.2019.08.921.

Branson RC, Hess DR, Kallet R, et al. American Association for Respiratory Care: SARS-

CoV-2 Guidance Document. American Association for Respiratory Care, 9425 N. MacArthur

Blvd., Ste 100, Irving TX 75063 T: 972.243.2272 W: www.aarc.org. Accessed April 19, 2020.

Centers for Disease Control and Prevention. Interim guidance for emergency medical services

(EMS) systems and 911 public safety answering points (PSAPs) for COVID-19 in the United

States. www.cdc.gov/coronavirus/ 2019-ncov/hcp/guidance-for-ems.html. Accessed March 20,

2020.

Fink S. Worst-case estimates for US coronavirus deaths. New York Times. March 13, 2020.

Gattinoni L, Coppola S, Cressoni M, et al. Covid-19 Does Not Lead to a “Typical” Acute

Respiratory Distress Syndrome. AJRCCM Articles in Press. Published March 30, 2020 as

10.1164/rccm.202003-0817LE.

Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate

surfaces and its inactivation with biocidal agents. J Hospit Infect. 2020:246-251.

Luks AM, Freer L, Grissom CK, et al. High Alt Med Biol. 2020 Apr 13. doi:

10.1089/ham.2020.0055. [Epub ahead of print].

Papazian L, Aubron C, Brochard L, et al. Formal guidelines: management of acute respiratory

distress syndrome. Ann. Intensive Care 9, 69 (2019). https://doi.org/10.1186/s13613-019-

0540-9.

Ramsey, L. 2020. Business Insider. March 6. https://www.businessinsider.com/presentation-

us-hospitals-preparing-for-millions-of-hospitalizations-2020-3.

Rawat J, Sindhwani G, Biswas D, et al. Role of BiPAP applied through endotracheal tube in

unconscious patients suffering from acute exacerbation of COPD: a pilot study. International

Journal of COPD 2012:7 321–325.

Rubinson L, Vaughn F, Nelson S, et al. Mechanical ventilators in US acute care hospitals.

Disaster Med Public Health Prep. 2010 Oct;4(3):199-206. doi: 10.1001/dmp.2010.18.

Siegel MD, Hyzy RC. UpToDate. November 26, 2019. www.uptodate.com/contents/ventilator-

management-strategies-for-adults-with-acute-respiratory-distress-syndrome. Accessed March

22, 2020.

Tran K, .Cimon K, Svern M, Pessoa-Silva CL, et al. (2012) Aerosol Generating Procedures

and Risk of Transmission of Acute Respiratory Infections to Healthcare Workers: A

Systematic Review. PLoS ONE 7(4): e35797. doi:10.1371/journal.pone.0035797.

U.S. Food & Drug Administration. Enforcement policy for ventilators and accessories and

other respiratory devices during the coronavirus disease 2019 (COVID-19) public health

emergency: guidance for industry and Food and Drug Administration Staff. March 2020.

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-

ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus. Accessed

March 20, 2020.

World Health Organization. Clinical management of severe acute-respiratory-infection when

novel coronavirus (nCoV) infection is suspected: interim guidance. March 13, 2020.

WHO/2019-nCoV/clinical/2020.4. https:// www.who.int/publications-detail/clinical-

management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-

suspected. Accessed March 20, 2020.