Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Wearable device-based perioperative monitoring: Participants will wear a study wearable device that continuously collects physiological and behavioral data, including heart rate, oxygen saturation, skin temperature, activity, sleep, and wearing status, from hospital admission to approximately 30 days after discharge. The device is used for monitoring and data collection and does not change routine clinical care.

Study summary

After thoracic surgery, some patients may develop complications such as lung infection, abnormal heart rhythm, fluid around the lung, prolonged air leak, wound infection, emergency department visits, or hospital readmission. These problems may not be found early if monitoring is only done during routine vital sign checks or follow-up visits.

This study will evaluate whether data collected by a wearable device can help identify early warning signs of postoperative complications in patients undergoing thoracic surgery. The wearable device will collect information such as heart rate, oxygen level, skin temperature, physical activity, sleep, and wearing status.

The study includes two parts. First, the researchers will review previously collected wearable device and medical record data to develop an early warning model. Second, new patients undergoing thoracic surgery will wear the device from hospital admission until about 30 days after discharge. The model will then be tested to see how well it predicts complications that require medical intervention within 30 days after surgery.

The main goal is to evaluate how accurately the wearable device-based model can identify patients who develop postoperative complications and how early the model can provide a warning before the complication is clinically confirmed.

Eligibility

Primary outcome measure(s)

• Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications — From the day of surgery to 30 days after surgery
  The area under the receiver operating characteristic curve will be used to evaluate the ability of the wearable device-based early warning model to distinguish participants who develop postoperative complications requiring medical intervention within 30 days after surgery from those who do not. Postoperative complications may include pulmonary infection, pleural effusion requiring treatment, prolonged air leak, wound infection, postoperative arrhythmia, emergency department visit, or hospital readmission.

Trial sites (1)

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