There are approximately 1.65 million Intensive Care Unit patients who are mechanically ventilated in the U.S. each year. In addition, mechanically ventilated patients are found in long-term acute care (LTAC) facilities, extended care and skilled nursing facilities, and in some home care settings. As a practicing pediatric cardiologist, I have witnessed the harmful consequences for both the patient and caregiver when the closed circuit of mechanical ventilation is broken in order to perform procedures, such as deep suctioning, that require the circuit to be opened.

Although there are systems on the market that allow for closed suctioning of patients, it is recognized that it is often necessary to disconnect the patient—that is, break the circuit—to achieve meaningful, effective suctioning assisted by manual Ambu bagging. Moreover, most respiratory therapists, if given the choice, would Ambu bag the patient while suctioning as this will result in a more effective pulmonary toilet. It also may be necessary, at times, to break the circuit when medication needs to be dispensed, pulmonary function tests need to be performed, and, in some cases, when bronchoscopic procedures are required.

 

Consequences breaking the circuit

As noted above, in order to accomplish deep and effective suctioning, it is often necessary to disassemble part of the respiratory support system either by removing the ventilator manifold or by opening a port and inserting a small diameter suction tube down the tracheal tube and into the patient’s trachea and lungs. The fluid is then suctioned from the patient and the suction catheter is removed and the respiratory support system is reassembled.

ADD_THIS_TEXT
 

Due to the high air pressure within the circuit, secretions that have built up in the system may end up being catapulted into the air upon opening. This loss of pressure and hence loss of PEEP (positive end expiratory pressure), often results in alveolar collapse, hypoxemia, and all the complications related to it. This also exposes the patient to the possibility of ventilator-acquired pneumonia and the caregiver to contamination.

Adults with ARDS (acute respiratory distress syndrome), immunocompromised patients, and premature babies are particularly vulnerable to these threats. For example, I had a personal experience with a baby born with pulmonary hypertension of the newborn. These babies are extremely sensitive to airway pressure changes and to changes in oxygenation. In the case of this delicate newborn, suctioning of the airways was extremely critical. Therefore, the circuit needed to be broken at one point during treatment to achieve deep, effective suctioning. This resulted in profound desaturation that placed the life of the baby at risk, and significantly prolonged his hospital stay due to complications from that event.

These unnecessary complications often lead to extended stays in the hospital, increased morbidity and mortality, and unnecessary treatment of the patient. It should not be surprising that these avoidable adverse outcomes contribute to the skyrocketing healthcare costs that we are experiencing in our country.

 

The BayWin Valve

My colleague Neil Winthrop, a registered respiratory therapist, and I set out to develop a way to build a device that could protect mechanically ventilated patients from the risks associated with breaking the closed circuit. We designed the BayWin Valve in collaboration with The Innovation Institute. The valve is a respiratory device that facilitates the protection of patients from ventilator-associated pneumonia and caregivers from the risk of infection from opening the ventilator circuit, while also providing optimal inhalation velocity.

The BayWin Valve is positioned within the inner chamber (see video below) where the flow between a manual resuscitation bag port and a ventilator port can be switched, enabling the patient to be treated without having to disconnect the respirator support system to thereby connect the resuscitation bag. Our design ensures that the closed circuit is not compromised during airflow manipulation. The BayWin Valve provides for smooth transitions and automatically reverts back to “normal” ventilation mode once the operator has completed ventilator care. This results in more beneficial patient outcomes and a safer work environment for caregivers.

I am certain that any caregiver familiar with the management of patients on ventilators has experienced the adverse results I described in this article. We believe the BayWin valve offers an alternative and safer way to manage intubated patients that require breaking the closed ventilator circuit. Use of the valve may be instrumental in improving outcomes in the intensive care units and other settings that provide care for mechanically ventilated patients, such as long-term acute care inpatient settings (LTAC).

We have been issued two U.S. patents (6,886,561; 8,656,925) and corresponding patents in Europe and Canada that cover key features of design. The Innovation Lab has also filed a provisional patent to protect recent design improvements. Currently, we are pursuing a dialogue with the experts at Cleveland Clinic for clinical feedback as well as Vyaire Medical and Halyard Health about their commercial interest in this impactful solution.

We are optimistic that our product will be deployed across health systems by early next year. Our hopes are that future long-term, multicenter studies on this device will show that the average patient hospital stay will be shortened, thus having powerful financial implications.

For more information, please visit www.ii4change.com.