Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery (wearable)
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.
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ni Zhang, MD
- Numer telefonu: +86-27-83665369
- E-mail: nizhang@tjh.tjmu.edu.cn
Lokalizacje studiów
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Hubei
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Wuhan, Hubei, Chiny, 430030
- Rekrutacyjny
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- Ni Zhang, MD
- Numer telefonu: +86-27-83665369
- E-mail: nizhang@tjh.tjmu.edu.cn
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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.
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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.
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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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications
Ramy czasowe: From the day of surgery to 30 days after surgery
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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.
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From the day of surgery to 30 days after surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Warning lead time before clinically confirmed postoperative complications
Ramy czasowe: From the day of surgery to 30 days after surgery
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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.
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From the day of surgery to 30 days after surgery
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Sensitivity of the wearable device-based early warning model for 30-day postoperative complications
Ramy czasowe: From the day of surgery to 30 days after surgery
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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.
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From the day of surgery to 30 days after surgery
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Specificity of the wearable device-based early warning model for 30-day postoperative complications
Ramy czasowe: From the day of surgery to 30 days after surgery
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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.
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From the day of surgery to 30 days after surgery
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TJ-IRB202512090 (Inny identyfikator: Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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