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

NCT07646730 | Recruiting DMC

• 1 other identifier: TJ-IRB202512090
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Thoracic Surgery; Perioperative Monitoring

Keywords

Wearable Device; Early Warning Model; Postoperative Complications; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications

  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.

  From the day of surgery to 30 days after surgery

Secondary Outcomes (3)

• Warning lead time before clinically confirmed postoperative complications

  From the day of surgery to 30 days after surgery

• Sensitivity of the wearable device-based early warning model for 30-day postoperative complications

  From the day of surgery to 30 days after surgery

• Specificity of the wearable device-based early warning model for 30-day postoperative complications

  From the day of surgery to 30 days after surgery

Study Arms (2)

Retrospective Cohort

Patients who previously underwent thoracic surgery and had available wearable device data and electronic medical record data during the perioperative period. This cohort will be used to evaluate agreement between wearable device measurements and routine clinical vital signs, analyze physiological signal trajectories before postoperative complications, and develop a preliminary early warning model.

Device: Wearable device-based perioperative monitoring

Prospective Validation Cohort

Newly enrolled patients scheduled for thoracic surgery who will wear the study wearable device from hospital admission to approximately 30 days after discharge. This cohort will be used to prospectively validate the wearable device-based early warning model for postoperative complications within 30 days after surgery.

Device: Wearable device-based perioperative monitoring

Interventions

Wearable device-based perioperative monitoring DEVICE

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.

Prospective Validation Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients aged 18 years or older who are hospitalized in the Department of Thoracic Surgery of Tongji Hospital and are scheduled to undergo thoracic surgery. Eligible patients should be able to wear the study-designated wearable device after hospital admission and are expected to continue wearing the device and/or uploading data within 30 days after discharge.

You may qualify if:

• Age 18 years or older.
• Hospitalized in the Department of Thoracic Surgery of Tongji Hospital and scheduled to undergo thoracic surgery.
• Able to wear the study-designated wearable device after hospital admission and expected to continue wearing the device and/or uploading data within 30 days after discharge.

You may not qualify if:

• Patients or family members are unwilling to wear the wearable device or unable to meet the required wearing time.
• Severe or unstable psychiatric disease, such as severe depression or schizophrenia.
• Pregnancy or lactation.
• Allergy to the watch strap material or local skin conditions that prevent wearing the device.
• Unable to complete follow-up within 30 days after discharge.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ni Zhang, MD

CONTACT

+86-27-83665369; nizhang@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Director of Department of Thoracic Surgery

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)