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APAP for ventilation

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Author: Prab R Tumpati, MD, founder WikiMD, Diplomate, ABIM, Sleep Medicine

WikiMD's proposal to deal with acute shortage of ventilators

According the following article available freely on NEJM, thanks to their policy of allowing all COVID-19 materials freely, it is projected that the United States and some other hard hit countries might soon run out of ventilators similar to the situation faced in Italy.

BiPAP
BiPAP

NEJM: "Acute care hospitals in the United States currently have about 62,000 full-function ventilators and about 98,000 basic ventilators, with an additional 8900 in the Office of the Assistant Secretary for Preparedness and Response Strategic National Stockpile.1 The Centers for Disease Control and Prevention estimates that 2.4 million to 21 million Americans will require hospitalization during the pandemic, and the experience in Italy has been that about 10 to 25% of hospitalized patients will require ventilation, in some cases for several weeks.2 On the basis of these estimates, the number of patients needing ventilation could range between 1.4 and 31 patients per ventilator. Whether it will be necessary to ration ventilators will depend on the pace of the pandemic and how many patients need ventilation at the same time, but many analysts warn that the risk is high."[1]

Our proposal for use of non-invasive ventilation

Proposal:: Hospitals should get more BiPAP's while waiting for more mechanical ventilators

As a board certified, practicing sleep medicine physician, I have first hand experience of how to use non-invasive means of ventilation such as CPAP/ Auto-PAP and BiPAP at patients homes successfully in treating patients with various sleep breathing disorders such as obstructive, central and mixed sleep apnea. As this is a treatment that can done with very little investment with ability to add oxygen as needed, it might act as a triage tool so that more severe patients can be put on full fledged ventilators while less severe patients are put on BiPAP with or without oxygen based on the situation, although certain modifications need to be made to meet the requirements set by the FDA.[2]

BiPAPs are better suited

Since Bilevel positive airway pressure devices are better suited for these, as CPAP's and or AutoPAPs do need some modifications to meet the FDA requirements, we suggest that hospitals invest in getting more BiPAP machines while awaiting more ventilators.

Modifications by the manufacturers to meet the needs

Here is a statement from Resmed, one of the leading manufacturers of the PAP devices.

Dear valued ResMed customer,

Amidst the rapidly evolving global situation caused by the coronavirus disease (COVID-19), we have received a number of inquiries regarding the recently released Food and Drug Administration’s (FDA) ventilator guidance, and wanted to provide some clarity from our perspective.

Can CPAPs be used as ventilators?

CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant mechanical and software rework to function as a ventilator.

FDA guidance on March 21-22, 2020 signals to manufacturers of respiratory equipment that modifications to devices capable of providing modes of ventilatory support that may be clinically applicable for COVID-19 patients can be considered if those modifications would not create undue risk for patients. To be clear, the FDA guidance does not signal that CPAPs can be used – as is – to treat the respiratory symptoms of COVID-19. The FDA still requires those potential modifications be made in a manner that is consistent with existing safety, quality, and manufacturing standards applicable to our devices.

Converting in-market CPAPs to support more advanced modes of ventilation requires careful assessment to ensure risk is acceptable, and must meet labeling requirements to be set forth by the FDA. We are currently exploring options for achieving this; at the same time, we are converting manufacturing resources typically used for PAP devices to support the manufacturing of bilevel and non-invasive ventilation devices that are more suited for the immediate care of COVID-19 patients. We are also ramping up production of invasive-capable and non-invasive ventilators to double our normal levels, while working closely with the U.S. Government and other government agencies to assess their needs.

Not recommended for ARDS

Since the fundamental problem in COVID-19 is ARDS, non-invasive ventilation is not recommended for severely hypoxic patients that are already in ARDS and can only be used in mildly hypoxic patients before they develop ARDS. Many patients will ultimately might need mechanical ventilators.[3]

Hospitals need to act fast

As BiPAP machines are widely available and can be procured at reasonable costs, it is important to procure these by hospitals, and other healthcare systems that care for these patients while they also do anything possible to get more mechanical ventilators.

CPAP flow
CPAP flow

Not new technology

While this is nothing new, and physicians have long used these devices as a bridge after surgery, or in milder cases that do not need a full mechanical ventilation, what is needed is large scale procurement of these devices in hard hit areas so that doctors are better able to make the triage decisions. For those patients that are able to keep their oxygenation with these devices, they can use these, and for more severe cases, a full mechanical ventilator should be used.[4]

External links

Wikipedia
UpToDate

References


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Latest research (Pubmed)

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