(I-337) Wireless Perioperative ECG using a Novel Smart Adhesive Wearable Device

Introduction:: Current standard of care for a patient undergoing anesthesia includes the monitoring of electrocardiogram (ECG) with five electrodes to detect heart rate and rhythm changes as well as any arrhythmias and myocardial ischemia. A significant functional limitation of anesthesia monitoring is the need for wired connections to the anesthesia machine, which can contribute to complexity while transporting patients and to medical error as patients are often briefly off the monitor while being transported from the operating room to the post anesthesia care unit (Fig. 1). Furthermore, current standard electrodes use gel and adhesives that can be irritating to the skin and cause a local sensitivity reaction, limiting how long they can be kept on the patient. Collectively, a new ECG monitoring system that is wireless, avoids the use of conductive gels, and is minimal in its form factor to provide safe and seamless ECG would improve anesthesia safety and efficiency in perioperative settings.

Materials and Methods:: A low-profile wireless ECG monitoring device (SKINTRONICS) with physical resemblance to a bandage was developed to realize wireless, accurate, and continuous ECG monitoring in perioperative environment. SKINTRONICS utilizes a highly breathable fabric-adhesive (9907T, 3M) as the adhesive substrate and has a footprint of 8 cm x 3 cm in its footprint and 0.3 mm in the thickness. The wireless module module (size: 3 cm x 2.5 cm x 0.3 cm) encased in an elastomeric enclosure is affixed to the center of the device using a one component adhesive (Sil-Poxy, Smooth-On) is embedded with a flexible circuit capable for Bluetooth communication, front-end amplification, and power management. A thin metal-plastic laminate (200 nm-thick gold coated on 8 µm-thick polyimide) was patterned using a femtosecond laser micromachining system (LS-Lab, LASEA) to fabricate stretchable, dry ECG electrodes (Fig. 2).

Results, Conclusions, and Discussions:: Device: 20 SKINTONICS devices configured with a 70 mAh rechargeable battery and 250 Hz sampling rate operated up to ~9 continuous hours while continuously transmitting ECG data to a connected mobile device. Average signal-to-noise ratio of measured ECG from two healthy subjects was 30.5 dB and the maximum wireless connectivity was ~10 m. Fully assembled devices was sterilized using hydrogen peroxide and low-temperature gas plasma (STERRAD NX System, ASP). (Fig. 3). Protocol: A total of 20 adult participants scheduled to undergo general or orthopedic surgery are recruited, while excluding those with history of or current atrial fibrillation, ASA status 4 or 5, or in emergency surgery. During surgery data from the standard wired ECG monitor will be collected using the S/5 Collect application (GE Healthcare), via a laptop connected directly to the monitor. Recording: Up to now, SKINTRONICS was successfully deployed in 7 cases to record continuous ECG throughout the procedures. There was no report of negative effects on the skin from wearing the SKINTRONICS. Conclusions: Preliminary results showed the SKINTRONICS’s functional capacity to assume the subsequent validation phase in perioperative settings. Statistical analysis of ECG will be performed to determine SKINTRONICS’s utility in perioperative settings. Finally, the electronic module will be enclosed with an elastomeric shell to further reduce device weight, improve mechanical flexibility, and provide an improved isolation from the environment .

Acknowledgements (Optional): : This is study is approved by the Mount Sinai's IRB (Study ID#: 22-01200).

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