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Mass Casualty Ventilation Monitoring

Periodic Reporting for period 1 - AIRMED (Mass Casualty Ventilation Monitoring)

Reporting period: 2020-09-01 to 2021-06-30

In case of viral epidemic or mass casualty, thousands of patients will die due the lack of critical care ventilators and human resources. Their complexity and high cost make it impossible to stockpile them. Low-cost mechanical ventilators exist but the lack of ventilation monitoring may lead to hyperventilation and serious risks of lung injuries leading to death in a high number of patients.
The use of low-cost ventilators is therefore strongly conditioned by the possibility to monitor ventilation parameters and give ventilation quality feedback combined with algorithms to identify and anticipate VNI failure (31% of patients), asynchrony, atelectasis, and rapid modification of lung characteristics.

AIRMED will be the first independent ventilation monitoring system for mechanically ventilated patients.
The system will be the first medical monitoring system to integrate AI to automatically adjust sensor calibration, interpret ventilation parameters according to patient’s need and automatically define target values. This device will therefore be able to guide rescuers in providing quality ventilation in emergency settings, even when no experienced medical team is available, and no advanced critical care ventilator can be used.
From September 2020 to June 2021, ARCHEON has been able to finalize the development of the prototypes which will be tested and validated with intensive care units and emergency teams in the year to come.
The development of new measurement algorithms, as well as the capability of the device to analyse in real time the lung profile of the patient has been demonstrated through technical tests on advanced artificial lungs.
Now the prototypes will be tested and validated in real clinical conditions on humans.
We expect to be ready to industrialize and homologate the product in the year to come.
The problem with current critical care ventilators (except from the expensive cost of acquisition) is that they do not integrate any automatic analysis algorithm to interpret in real time ventilation parameters. Most of the caregivers do not have the same theoretical knowledge than anesthesiologists or respiratory therapists about ventilation. The simple display of quantitative variables, whose interpretation with regard to the characteristics of the patient and the situation encountered is complex, can be an obstacle to the achievement of quality ventilation.

This is why our system will integrate an artificial intelligence allowing a self-interpretation of the measured variables according to the morphology of the patient and the type of ventilation performed (invasive or not). This self-interpretation, which will be a major characteristic of the future product, is made possible only thanks to the modelization of patient’s lung profiles we were able to develop these recent years when working on EOlife previous product.
Depending on the situation, the system will decide to favor the quality of one parameter regarding to another one to produce minimum oxygenation and carbon dioxide removal while maintaining protective ventilation, or on the contrary to favor the administration of oxygen if the patient is not sufficiently ventilated.

The main market for the AIRMED device will concern the emergency and intensive care departments as well as the composition of strategic stocks for the “advanced medical posts”.
In France, the number of patients who can be admitted to intensive care reaches 5,500 and is about 46,000 beds in Europe. The World Health Organization estimate a total number of 325,000 intensive care beds worldwide.
In addition, and to anticipate the various threats and to secure the State's response capacity, the governments regularly define and revise a series of response plans themed by type of threat. These plans are supplemented, for their operational deployment, by a strategy for the acquisition of health products and medical devices distributed to the population in the event of an exceptional health event. The constitution of this stock favors a rapid intervention of the State in the event of a large-scale event and thus makes it possible to overcome the difficulties drawn from a supply of saturated care and from a global system under stress. It also secures the supply of specific health products.

In a study carried out in 2000, adequate ventilation applied to 861 patients suffering from acute respiratory distress led to a 9% absolute decrease in mortality. Another recent study carried out on 980 patients also demonstrated that a comprehensive ventilation strategy in the emergency department was associated with reduced mortality by 15% and fewer ventilator days.
We have no doubt that using AIRMED device in intensive care and emergency departments when no critical care ventilator is available would help to make a big difference in fighting a viral epidemic such as Covid-19. Efficient ventilation reduces after-effects and undesirable events and thus improve survival rate by at least 15%, which would represent in a normal situation with no epidemic at least 2 500 lives saved each year in France and 850,000 lives worldwide.

Moreover, lung infections are very common in intubated patients undergoing mechanical ventilation, with several series reporting an incidence of up to 70%, mainly induced by hyperventilation and improper airway management [6]. Performing efficient ventilation from the very first moments of an emergency intervention would reduce these risks of infection and thus reduce the length of stay in intensive care unit by approximately 2.4 days, hence a reduction of cost of care by more than 3 800 € per patient. Another important impact of this technology is to provide real-time feedback of ventilation quality to emerging markets and countries where mechanical ventilators are never available even in operating rooms and care centers because of expensive costs (between 20-30 k€) and unaffordable disposable parts.
Finalized Prototype
Finalized Prototype with Silicone protection