General GuidelineThe MIT E-Vent design guideline used in the A3B Vent. is intended for emergency use only when all available conventional invasive respiratory support has been exhausted. It should only be used in a clinical environment under careful monitoring by trained medical professionals. This has been developed by a team of physicians certified in Anesthesia and Critical Care, working with mechanical, electrical, and software engineers.
- A deteriorating COVID-19 patient, who is short of breath & hypoxic; hypoxemic respiratory insufficiency means they are not breathing well enough to adequately oxygenate their blood. Clinicians at this point can initiate respiratory support. An MIT E-Vent could provide basic respiratory support in this situation
- Worsening clinical status recognized when a patient develops Acute Respiratory Distress Syndrome (ARDS). An MIT E-Vent could be a bridging solution until a traditional ICU ventilator becomes available
- The patient will be intubated or have a tracheostomy (limited / no applicability to mask)
- Those patients are otherwise going to be sedated and paralyzed (invasive ventilation requires sedation, and paralysis will prevent patient-ventilator dyssynchrony if assist-control is not available)
- Ventilated patients required to leave the ICU for imaging or procedures can be supported with the MIT E-Vent, unless determined that the patient requires support outside its range.
Important: A multidisciplinary team consisting of a physician, critical care nurse, and respiratory therapist should be available to monitor ventilated patients at all times. Additionally, a clinical lab capable of timely reporting of blood gases and other common ICU laboratory markers should be available to enable the clinical team to make appropriate decisions and adjustments.
Acute Respiratory Distress Syndrome
Those patients with ARDS would preferentially receive mechanical ventilation by standard ICU ventilators. A manual resuscitator is meant as a backup should institutions run out of traditional ventilators, and for patients with milder forms of lung disease that require less sophisticated modes and features.
Changes in lung mechanics (compliance) can be a result of acute and chronic lung conditions. In general, lung compliance is affected by a multitude of factors; in ARDS, fluid is present in the alveoli and/or interstitial space (between the alveoli and a capillary blood vessel) and results in changes in the diffusion of gases between the alveoli and blood vessel. Other conditions include:
- Any pathologies that cause fluid accumulation in the lung (‘wet lung’) through infectious, inflammatory, mechanical, or hydrostatic factors (pulmonary edema, TRALI, pneumonia, pneumonitis, diffuse alveolar hemorrhage, heart failure, cardiogenic shock, mitral valve regurgitation)
- Any pathology that causes fibrosis (scarring and thus stiffening – ‘stiff lung’) of the lung structure, otherwise known as the “parenchyma” (ARDS related, interstitial lung disease, sarcoidosis, idiopathic pulmonary fibrosis, radiation or chemotherapy-related, post pneumonia or hemothorax related trapped lung or lung fibrosis)
The safe limit for ventilation therapy has not yet been determined. In the life-and-death situation we are currently facing, this will give patients a chance until an ICU or OR ventilator becomes available. We are actively engaging with animal testing laboratories to determine what, if any, these limitations may be. Further, we plan to perform multi-day trials in pigs to evaluate the safety of longer-term MIT E-Vent use.