Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device
16. september 2026 oppdatert av: Kunjing Pang
The goal of this observational study is to learn if a wearable heart ultrasound system with automated analysis works as well as standard bedside ultrasound for continuous heart function monitoring in adults and children with severe heart conditions in intensive care units (ICUs). The study will also test if the system can help guide minimally invasive procedures for structural heart defects. About 610 people will take part in this research.
The main questions it aims to answer are:
- Do heart function measurements from the wearable ultrasound system match results from standard bedside ultrasound exams?
- How accurately can the automated analysis tool measure heart function using images from the wearable device?
- Is it feasible and safe to use the wearable ultrasound system to help guide minimally invasive closure of heart defects?
Researchers will compare readings collected by the wearable ultrasound device to results from standard bedside ultrasound exams. They will check how closely the two methods agree to see if the wearable system can replace standard testing for ongoing heart monitoring. The research team will remove all personal identifiers from all study data to protect each participant's privacy.
Participants will:
- Wear a small, soft ultrasound patch on their chest to continuously monitor their heart structure and function
- Receive standard bedside ultrasound exams as part of their routine intensive care
- Allow the research team to collect their heart images and vital signs (heart rate, blood pressure, and oxygen levels) for study analysis
- If they receive a minimally invasive procedure to fix a heart defect, the research team will use the wearable ultrasound device during the procedure to help guide treatment
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kunjing Pang
- Telefonnummer: 13520114557
- E-post: pangkunjing2020@126.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adult patients with perioperative cardiopulmonary critical illness admitted to the adult ICU or CCU at Fuwai Hospital, including patients with coronary artery disease or valvular heart disease after cardiac surgery, and patients undergoing interventional procedures for structural heart disease.
- Pediatric patients with perioperative cardiopulmonary critical illness admitted to the pediatric intensive care unit (PICU) at Fuwai Hospital, including patients with congenital heart disease after cardiac surgery.
Exclusion Criteria:
- Severe wound infection or delayed thoracic closure that prevents placement of the wearable cardiac ultrasound monitoring device.
- Patient or family refusal to participate in the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Wearable Cardiac Ultrasound Monitoring
Participants will undergo continuous cardiac structure and function monitoring with the wearable cardiac ultrasound system.
They will also receive standard bedside echocardiography as routine clinical care.
The study team will compare measurements from the wearable device with results from standard echocardiography to evaluate the accuracy and consistency of the wearable system.
|
A soft, wearable ultrasound patch is applied to the participant's chest to continuously acquire cardiac ultrasound images.
The system performs real-time 2D echocardiographic imaging, Doppler assessment, and automated cardiac function measurement.
Ultrasound data is transmitted wirelessly for remote review by experienced sonographers, and synchronized with bedside vital sign monitors.
Study staff compare measurements from the wearable system with results from standard bedside echocardiography to evaluate consistency and accuracy.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography
Tidsramme: Day 1
|
LVEF (%) measured from wearable cardiac ultrasound images will be compared with LVEF (%) measured by an experienced echocardiographer using standard bedside echocardiography.
The primary outcome is the mean difference in LVEF between the two methods, calculated as wearable cardiac ultrasound minus standard bedside echocardiography.
The mean difference and its 95% confidence interval will be calculated.
Bland-Altman analysis will also be performed to estimate the 95% limits of agreement between the two methods.
|
Day 1
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Zou F, Luo Y, Zhuang W, Xu T. A Fully Integrated Conformal Wearable Ultrasound Patch for Continuous Sonodynamic Therapy. Adv Mater. 2024 Sep;36(39):e2409528. doi: 10.1002/adma.202409528. Epub 2024 Aug 6.
- Chu Y, Li C, Zhang W, et al. Human pulse diagnosis for medical assessments using a wearable piezoelectret sensing system. Adv Funct Mater. 2018 Oct;28(40):1803413.
- Zhang L, Yu K, Wang Y, et al. A conformable phased-array ultrasound patch for bladder volume monitoring. Nat Electron. 2024 Jan;7(1):77-90.
- Du W, Zhang L, Suh E, Lin D, Marcus C, Ozkan L, Ahuja A, Fernandez S, Shuvo II, Sadat D, Liu W, Li F, Chandrakasan AP, Ozmen T, Dagdeviren C. Conformable ultrasound breast patch for deep tissue scanning and imaging. Sci Adv. 2023 Jul 28;9(30):eadh5325. doi: 10.1126/sciadv.adh5325. Epub 2023 Jul 28.
- Liu HC, Zeng Y, Gong C, Chen X, Kijanka P, Zhang J, Genyk Y, Tchelepi H, Wang C, Zhou Q, Zhao X. Wearable bioadhesive ultrasound shear wave elastography. Sci Adv. 2024 Feb 9;10(6):eadk8426. doi: 10.1126/sciadv.adk8426. Epub 2024 Feb 9.
- Wang C, Chen X, Wang L, Makihata M, Liu HC, Zhou T, Zhao X. Bioadhesive ultrasound for long-term continuous imaging of diverse organs. Science. 2022 Jul 29;377(6605):517-523. doi: 10.1126/science.abo2542. Epub 2022 Jul 28.
- Min S, An J, Lee JH, Kim JH, Joe DJ, Eom SH, Yoo CD, Ahn HS, Hwang JY, Xu S, Rogers JA, Lee KJ. Wearable blood pressure sensors for cardiovascular monitoring and machine learning algorithms for blood pressure estimation. Nat Rev Cardiol. 2025 Sep;22(9):629-648. doi: 10.1038/s41569-025-01127-0. Epub 2025 Feb 18.
- Hu H, Huang H, Li M, Gao X, Yin L, Qi R, Wu RS, Chen X, Ma Y, Shi K, Li C, Maus TM, Huang B, Lu C, Lin M, Zhou S, Lou Z, Gu Y, Chen Y, Lei Y, Wang X, Wang R, Yue W, Yang X, Bian Y, Mu J, Park G, Xiang S, Cai S, Corey PW, Wang J, Xu S. A wearable cardiac ultrasound imager. Nature. 2023 Jan;613(7945):667-675. doi: 10.1038/s41586-022-05498-z. Epub 2023 Jan 25.
- Sempionatto JR, Lin M, Yin L, De la Paz E, Pei K, Sonsa-Ard T, de Loyola Silva AN, Khorshed AA, Zhang F, Tostado N, Xu S, Wang J. An epidermal patch for the simultaneous monitoring of haemodynamic and metabolic biomarkers. Nat Biomed Eng. 2021 Jul;5(7):737-748. doi: 10.1038/s41551-021-00685-1. Epub 2021 Feb 15.
- Wang C, Li X, Hu H, Zhang L, Huang Z, Lin M, Zhang Z, Yin Z, Huang B, Gong H, Bhaskaran S, Gu Y, Makihata M, Guo Y, Lei Y, Chen Y, Wang C, Li Y, Zhang T, Chen Z, Pisano AP, Zhang L, Zhou Q, Xu S. Monitoring of the central blood pressure waveform via a conformal ultrasonic device. Nat Biomed Eng. 2018 Sep;2(9):687-695. doi: 10.1038/s41551-018-0287-x. Epub 2018 Sep 11.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
5. september 2026
Primær fullføring (Antatt)
5. september 2028
Studiet fullført (Antatt)
16. mars 2029
Datoer for studieregistrering
Først innsendt
9. september 2026
Først innsendt som oppfylte QC-kriteriene
16. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-ZX041
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared to protect the privacy and confidentiality of study participants.
The dataset contains sensitive clinical medical records and identifiable cardiac imaging data of critically ill patients, which are governed by institutional data security policies and ethical review requirements.
No external data sharing plan is designated for this study.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .