ECLERIS CONSIDERATIONS WITH REFERENCE TO THE USE OF

THE HELMET FOR NON-INVASIVE VENTILATION/CPAP DURING

THE COVID 19 PANDEMIC

GENERAL CONCEPTS:

- The virus does not always have the same behavior. In medicine this is known as
phenotypes, which means the way the organism behaves within the environment.
There could be more aggressive viruses, which could attack even younger people
and cause faster respiratory damage. This is what happened in Italy, in places such
as in Lombardy, where the virus had an extremely aggressive pattern with a RO of 3
or 4 (one patient infects 3 or 4 people), while in Northeast Italy the RO was 2.

- Hospitals usually don’t have enough ICU beds. One of the KOL we take into consid-
eration is Professor Stefano Nava, head of the Respiratory Critical Care Unit at the
Sant’ Orsola Hospital in Bologna. They had 60 ICU beds in a 1250 bed hospital. This is a
common situation in many hospitals. In Italy there are 10 times less ICU beds than in
the USA, of course taking into account the difference in size of both populations.

- A high percentage of patients who arrive at the Hospital affected by COVID 19

need oxygen. The protocol consists in administering the ventilation support needed
according to the patient’s condition and available resources on site. In this hospital
100 patients who arrived on the same day needed intubation and there were not
enough ICU beds, ventilators or trained staff to take care of such amount of patients.

- Training physicians and other healthcare personnel before spikes of infections occur
is extremely important. Such training should be based on non-invasive ventilation
techniques and CPAP, leaving intubations to experts, usually ICU therapists, anesthesi-
ologists and pulmonologists.

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CONSIDERACIONES RESPECTO DEL CASCO PARA VENTILACION
NO INVASIVA/CPAP EN LA PANDEMIA POR COVID 19

- It is extremely important to have the right protective gear for all health workers, as
they are the ones who will be attending to the infected patients.

- It is extremely important to have the right protective gear for all health workers, as
they are the ones who will be attending to the infected patients.

ECLERIS HELMET FOR NON-INVASIVE VENTILATION/CPAP

There is no doubt that Italy is the country that gained the most experience in the use of
these helmets, although they were also used in France and now, the USA is starting to
use them as well. Spain, England and other countries that have had significant infec-
tious peaks have not been able to use them because they were not available in the
market. Most of the world's stock of these helmets was acquired by Italy.

The helmet is a non-invasive ventilation option and the safest for the staff. And a big
advantage of Ecleris helmet is that it is reusable, after a correct disinfection.

PATIENT SELECTION PROTOCOL

When a patient arrives at the hospital or health institution, a selection protocol, known
as Triage, is followed based on the patient’s signs and symptoms. The Triage is a
method of patient selection and classification during emergencies, based on thera-
peutic needs and available resources.

Each hospital follows its own protocol but in general the following criteria are taken
into account (simplified of course):

- Oxygen blood saturation.

- Breathing rate.

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NO INVASIVA/CPAP EN LA PANDEMIA POR COVID 19

These patients are classified into groups:

• Green: Sa O2 greater than 94% and RF less than 20/minute. This patient usually is sent
back home.

• Yellow: Sa O2 less than 94% and RF greater than 20/minute. This patient is referred to
common areas of the hospital and supplied with oxygen. If the above mentioned
parameters do not improve supplying oxygen at 10 to 15 l/minute they should be trans-
ferred to the next stage.

• Orange: Patients who need Continuous Positive Airway Pressure Ventilation (CPAP).
There are basically three options (helmet, mask and nasal cannula). The helmet is the
first choice, if available. If the patients respond, they may be treated by a physician
not specialized in ventilation support. If they do not respond, they are classified as red
category. Normally the test time to evaluate if patients respond to the treatment with
the helmet is about 4 to 6 hours. The test is done with 60% oxygen and PEEP 10/12
without humidification. If the Sa O2 rises to more than 95% and/or the breathing rate
drops below 28 , the helmet oxygen supply is recommended to be continued. If
instead, the Sa O2 drops below 95% and/or RF is above 28, endotracheal intubation
must be considered. In Professor Nava's experience, 40% of patients treated with the
helmet improved within 2 to 5 days.

• Red: The patient must be moved to the ICU and most likely will need Invasive Me-
chanical Ventilation, a ventilator.

The conclusion is that many patients will be needing ventilation, and early ventilation
without an endotracheal tube saves lives. The NIV/CPAP helmet is the alternative to
intubation with the lowest risk of staff contamination because it eliminates the risk of
the virus becoming airborne, something that happens with other techniques such as
using high oxygen flow with nasal cannula or mask.

Studies have shown that the dispersion of the virus with HNF (high nasal flow) if not
perfectly placed is about 60 cm and can reach 2.4 meters if the patient coughs.

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CONSIDERACIONES RESPECTO DEL CASCO PARA VENTILACION
NO INVASIVA/CPAP EN LA PANDEMIA POR COVID 19

APPLICATIONS OF THE ECLERIS NIV/CPAP HELMET:

The helmet is an alternative to endotracheal Intubation and Invasive Mechanical Ventila-

tion in cases of Acute Respiratory Failure produced by COVID 19 in the following situa-
tions:

• As a start-up therapy in selected cases.

• As a bridge therapy until the start of IMV.
• As the only therapy when no ventilator is available.
• For extra hospital ventilation support in primary care centers or points of continuous
care until transfer to a hospital.
• As palliative therapy in selected cases.
• In the weaning phase of Invasive Mechanical Ventilation.
• In patients with no intubation indication and in very elderly patients (>85 years).

Sources considered for this document:

- Professor Stefano Nava, head of the Respiratory Critical Care Unit at the Sant’ Orsola Hospital in Bologna.
- Professor Paolo Pelosi, Doctor of the Special College of Anesthesiology of the University of Genoa, Italy.
- Professor Manuel Lujan, Consultant in Respiratory Medicine, Hospital Sabadell, Barcelona, Spain.
- Professor Julien Pottecher, specialist in Anesthesia and Intensive Therapy, University Hospital in Strasbourg,
France.

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