Postoperative ComplicationswearableNCT07646730
Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery
An observational study of Postoperative Complications and Thoracic Surgery, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Thoracic Surgery, Perioperative Monitoring
- What is being tested?
- Wearable device-based perioperative monitoring
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ni Zhang, MD, +86-27-83665369, nizhang@tjh.tjmu.edu.cn
About this study
Official title: Development and Validation of a Wearable Device-Based Early Warning Model for Postoperative Complications in Thoracic Surgery: A Retrospective and Prospective Cohort Study
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.
Read more
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.
Read the detailed description
Postoperative complications are an important concern after thoracic surgery. Conventional perioperative monitoring mainly relies on intermittent vital sign measurements, nursing assessments, physician rounds, and routine post-discharge follow-up. This approach may miss short-lasting, nighttime, or activity-related physiological changes that occur before a complication becomes clinically apparent.
Wearable devices can continuously collect physiological and behavioral information, including heart rate, oxygen saturation, skin temperature, activity, sleep, and wearing status. Combining these data with electronic medical record information may help identify early changes associated with postoperative complications.
This study uses a retrospective and prospective cohort design. In the retrospective stage, previously collected wearable device data and electronic medical record data from thoracic surgery patients will be analyzed. The researchers will evaluate the agreement between wearable device measurements and routine clinical vital signs, describe physiological signal patterns before postoperative complications, and develop a preliminary early warning model.
In the prospective validation stage, newly enrolled patients scheduled for thoracic surgery will wear the study wearable device from hospital admission to approximately 30 days after discharge. The early warning model developed from the retrospective data will be applied prospectively using predefined parameters. Model-generated warnings will be recorded. The occurrence of postoperative complications will be verified through inpatient medical records and follow-up after discharge.
The primary reference outcome is postoperative complications requiring medical intervention within 30 days after surgery. These complications may include pulmonary infection, pleural effusion requiring treatment, prolonged air leak, wound infection, postoperative arrhythmia, emergency department visit, or readmission. Model performance will be evaluated using sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and warning lead time. Wearable device adherence, data completeness, and the added predictive value of wearable device-derived features beyond routine clinical variables will also be assessed.
- Being tested
- Wearable device-based perioperative monitoring
- Keywords
- Wearable Device, Early Warning Model, Postoperative Complications, Thoracic Surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable device-based perioperative monitoringDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wearable device-based perioperative monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of surgery to 30 days after surgery
Secondary outcomes (3)
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.
Measured: From the day of surgery to 30 days after surgery
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.
Measured: From the day of surgery to 30 days after surgery
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.
Measured: From the day of surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start16 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646730
- Sponsor's protocol ID
- TJ-IRB202512090
- Other IDs
- TJ-IRB202512090
- Acronym
- wearable
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared because the study data include wearable device monitoring data and clinical information from electronic medical records, which may contain sensitive health information. Only aggregate results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Wearable Device-Based Early Warning Model for Postoperative Complications in Thoracic Surgery: A Retrospective and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07646730
- Acronym / sponsor ID
- wearable / TJ-IRB202512090
- Keywords
- Wearable Device, Early Warning Model, Postoperative Complications, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative complications are an important concern after thoracic surgery. Conventional perioperative monitoring mainly relies on intermittent vital sign measurements, nursing assessments, physician rounds, and routine post-discharge follow-up. This approach may miss short-lasting, nighttime, or activity-related physiological changes that occur before a complication becomes clinically apparent.
Wearable devices can continuously collect physiological and behavioral information, including heart rate, oxygen saturation, skin temperature, activity, sleep, and wearing status. Combining these data with electronic medical record information may help identify early changes associated with postoperative complications.
This study uses a retrospective and prospective cohort design. In the retrospective stage, previously collected wearable device data and electronic medical record data from thoracic surgery patients will be analyzed. The researchers will evaluate the agreement between wearable device measurements and routine clinical vital signs, describe physiological signal patterns before postoperative complications, and develop a preliminary early warning model.
In the prospective validation stage, newly enrolled patients scheduled for thoracic surgery will wear the study wearable device from hospital admission to approximately 30 days after discharge. The early warning model developed from the retrospective data will be applied prospectively using predefined parameters. Model-generated warnings will be recorded. The occurrence of postoperative complications will be verified through inpatient medical records and follow-up after discharge.
The primary reference outcome is postoperative complications requiring medical intervention within 30 days after surgery. These complications may include pulmonary infection, pleural effusion requiring treatment, prolonged air leak, wound infection, postoperative arrhythmia, emergency department visit, or readmission. Model performance will be evaluated using sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and warning lead time. Wearable device adherence, data completeness, and the added predictive value of wearable device-derived features beyond routine clinical variables will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Device: Wearable device-based perioperative monitoringPatients 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. |
| Prospective Validation Cohort | – | Device: Wearable device-based perioperative monitoringNewly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable device-based perioperative monitoringParticipants 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. | Device | Prospective Validation Cohort, Retrospective Cohort |
Primary outcome
Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications
Time frame: 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.
3 secondary outcomes
Warning lead time before clinically confirmed postoperative complications
Time frame: From the day of surgery to 30 days after surgery
Sensitivity of the wearable device-based early warning model for 30-day postoperative complications
Time frame: From the day of surgery to 30 days after surgery
Specificity of the wearable device-based early warning model for 30-day postoperative complications
Time frame: From the day of surgery to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared because the study data include wearable device monitoring data and clinical information from electronic medical records, which may contain sensitive health information. Only aggregate results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Thoracic Surgery, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ni Zhang, MD (+86-27-83665369, nizhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications (time frame: From the day of surgery to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.