Georgia Tech graduates, Haris Shekhani and Prathamesh Prabhudesai, are physicians by training who co-founded SafeBVM Corp. to develop novel non-invasive technology solutions for assisting providers to deliver safe and optimal manual ventilation.
During manual ventilation with the resuscitation bag, air enters the stomach (gastric insufflation) 71% of the time1. It causes the stomach to distend, generating an upward thrust on the diaphragm, thus decreasing space for the lungs to expand. Due to stomach distention, blood flow is diverted to the stomach thus further reducing blood oxygenation by 65%2. Vomiting is another common complication. 1 out of 3 out-of-hospital cardiac arrest patients exhibits vomiting3,4. It frequently leads to severe complications like aspiration pneumonia and Acute Respiratory Distress Syndrome (ARDS).
Over the past few decades, there have been several innovations addressing the problem of poor manual ventilation via resuscitation bag leading to air entry into the stomach. The endotracheal tube (ET) and supraglottic airway devices (SGA) such as the Laryngeal Mask Airway (LMA), King LT, and iGel SGA, prevent air-entry into the stomach by creating an anatomical change in the airflow pathway, ensuring that air is only delivered to the lungs. Despite their proven efficacy, these devices are invasive, require high skill and training, and do not consider the correct methodology of squeezing the bag.
SafeBVM Corp. has developed the SIP™ Safety Accessory to the resuscitation bag to address the problem of gastric insufflation in a cost-effective and user-friendly manner. Instead of anatomically blocking airflow to the esophagus, the device creates a functional block and directs air to the lungs by utilizing physiological characteristics of airflow. The device snugly fits between the bag and an outlet device, be it the mask/ET tube/the SGA device. It ensures that every time a provider squeezes the resuscitation bag, the critical parameters of airflow generated and delivered are safe and optimal. If the provider squeezes the bag too forcefully, the device creates tension within the resuscitation bag. The tension is felt on the provider’s palm(s) as a recoil, signifying an improper squeeze. This feedback functions as a training mechanism assisting the provider to change the ventilation technique and deliver air optimally. The resulting squeezes produce breaths that have an optimal flow, pressure, increased inspiratory time, higher I:E ratio, and longer rise time, thus creating greater compliance with the current AHA guidelines. The device is dynamic and adjusts optimal airflow according to airway resistance and lung compliance of the patient being ventilated. It delivers set tidal volume with the lowest pressure possible,making the resuscitation bag function like a commonly used mode in the ventilator- Pressure Regulated Volume Control (PRVC).
Haris and Prathamesh had started this journey two years back at the EMS World Expo 2017 in Las Vegas, where they first began exploring unmet clinical needs in the EMS domain. They have come a long way. Their device is in the preclinical phase, yet to receive FDA clearance. SafeBVM recently conducted a 20-provider usability study at Trauma in the Delta 2019 Training Conference at the University of Arkansas for Medical Sciences-East Campus. They also partnered with the Paragon Medical Education Group lead by Joe Holley, MD, for preliminary evaluation of their product on fresh cadavers and obtained promising results. They aim to conduct additional, comprehensive studies next year. Currently, out of 70 product entries for this year, the SIP™ Safety Accessory has been selected as finalists in the 2019 EMS WORLD EXPO Innovation Awards. SafeBVM is indeed a great example of how the EMSWorld Expo can help bring innovation to the EMS!
Find out more about them at www.safebvm.com. To connect in person during this year's EMS World Expo, please contact Haris Shekhani at firstname.lastname@example.org/ +1 (314) 973-6606.
Vasudevan A, Srinivasan S, Vinayagam S, Ramkumar G, Senthilnathan M. Assessment of effectiveness of cricoid pressure in preventing gastric insufflation during bag and mask ventilation: A randomized controlled trial. Saudi J Anaesth. 2018;12(4):606-611.
Braun P, Putzer G, Strapazzon G, et al. Effects of Stomach Inflation on Cardiopulmonary Function and Survival During Hemorrhagic Shock: A Randomized, Controlled, Porcine Study. Shock. 2016;46(1):99-105.
Virkkunen I, Ryynänen S, Kujala S, et al. Incidence of regurgitation and pulmonary aspiration of gastric contents in survivors from out-of-hospital cardiac arrest. Acta Anaesthesiol Scand. 2007;51(2):202-5.
Simons RW, Rea TD, Becker LJ, Eisenberg MS. The incidence and significance of emesis associated with out-of-hospital cardiac arrest. Resuscitation. 2007;74(3):427-31.
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