Wearable Device for Postoperative Hemorrhage

(VYSIO-FEASIBIL Trial)

This trial aims to determine if a new wearable device, called Hemorai Vysio, can safely track changes in blood flow and oxygen use during and after surgery. The device records data but does not provide direct medical measurements or influence care decisions. The trial will also assess potential issues like skin irritation and evaluate the device's comfort for patients and nurses. It suits individuals undergoing surgery with an overnight hospital stay who can wear sensors on their skin. Participants will not receive direct medical benefits, but their involvement could help improve future surgical care. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Without specific safety data for the Hemorai Vysio wearable device, it is important to note that the trial is labeled as "Not Applicable" in terms of phase. This designation typically means the device is still under study for safety and effectiveness and has not yet received full approval for widespread use.

Researchers will monitor participants for any issues with the device, such as skin irritation or discomfort. The device tracks changes in tissue oxygen and blood flow without interfering with regular care, but it does not provide medical measurements used for treatment decisions.

The Hemorai Vysio wearable device is unique because it offers a new way to monitor patients for postoperative hemorrhage using optical signals, which is not part of the standard care currently involving visual assessments and vital sign monitoring. Unlike traditional methods that rely on subjective observations and intermittent checks, this device provides continuous, real-time data collection when worn on the upper arm or chest. Researchers are excited about this technology because it has the potential to detect bleeding more quickly and accurately, improving patient outcomes and reducing the need for more invasive procedures.

Research has shown that the Hemorai Vysio wearable device can monitor changes in hemoglobin and oxygen levels, aiding in the early detection of blood loss during and after surgery. In this trial, participants will wear the Hemorai Vysio device, which effectively tracks these vital signs and may help predict and respond to bleeding. Although the device remains under testing, its ability to monitor these changes could make surgeries safer by identifying problems early. However, it is important to note that the device does not provide direct medical benefits during the trial, as its data is used solely for research purposes.⁶⁷⁸