Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Wearable device-based perioperative monitoring
DeviceParticipants 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.
Treatment groups
650 Participants
are divided into 2 treatment groupsGroup A: Retrospective Cohort1 intervention
Group B: Prospective Validation Cohort1 intervention
Trial outcomes
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.
Time frame
From the day of surgery to 30 days after surgerySecondary outcomes
1
Warning lead time before clinically confirmed postoperative complications
Warning lead time will be defined as the time interval between the first model-generated warning signal and the clinical confirmation of a postoperative complication requiring medical intervention.
Time frame
From the day of surgery to 30 days after surgery2
Sensitivity of the wearable device-based early warning model for 30-day postoperative complications
Sensitivity will be defined as the proportion of participants with postoperative complications requiring medical intervention within 30 days after surgery who are correctly identified by the wearable device-based early warning model.
Time frame
From the day of surgery to 30 days after surgery3
Specificity of the wearable device-based early warning model for 30-day postoperative complications
Specificity will be defined as the proportion of participants without postoperative complications requiring medical intervention within 30 days after surgery who are correctly classified as not having a warning signal by the wearable device-based early warning model.
Time frame
From the day of surgery to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov