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

12. Juni 2026 aktualisiert von: Zhang Ni, Tongji Hospital

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

650

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Rekrutierung
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

  1. Age 18 years or older.
  2. Hospitalized in the Department of Thoracic Surgery of Tongji Hospital and scheduled to undergo thoracic surgery.
  3. 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:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Gerät: 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.
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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area under the receiver operating characteristic curve of the wearable device-based early warning model for 30-day postoperative complications
Zeitfenster: 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.
From the day of surgery to 30 days after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Warning lead time before clinically confirmed postoperative complications
Zeitfenster: From the day of surgery to 30 days after surgery
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.
From the day of surgery to 30 days after surgery
Sensitivity of the wearable device-based early warning model for 30-day postoperative complications
Zeitfenster: From the day of surgery to 30 days after surgery
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.
From the day of surgery to 30 days after surgery
Specificity of the wearable device-based early warning model for 30-day postoperative complications
Zeitfenster: From the day of surgery to 30 days after surgery
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.
From the day of surgery to 30 days after surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tongji Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Dezember 2025

Primärer Abschluss (Geschätzt)

30. November 2026

Studienabschluss (Geschätzt)

15. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TJ-IRB202512090 (Andere Kennung: Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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