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Completed

NCT Number: NCT06096922

AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery

The main purpose of this study is to establish a frailty automatic evaluation index "AI frailty index" based on artificial intelligence multi-modal non-contact monitoring information analysis. At the same time, the study will explore the correlation between ' AI weakness index ' and perioperative and long-term prognosis and quality of life.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

About this study

This is a prospective cohort study. Patients who undergoes elective cardiac surgery will be enrolled. We collect frailty scales, clinical information and multi-modal, non-contact monitoring information during hospitalization. One-year follow-up will be done. The non-contact monitoring information are used to predict the frailty scales to establish and validate an AI-based frailty assessment model "AI frailty index". The AI frailty index will be further used to predict perioperative and long-term outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiac surgery

Exclusion criteria

  • Emergency surgery
  • Age ≤ 18 years
  • The clinical situation is unstable, such as frequent occurrence of coronary ischemia events, unstable heart failure, or acute events leading to severe discomfort symptoms or changes in vital signs
  • Unable to cooperate in completing research data collection due to severe neurological and psychiatric abnormalities or other reasons
  • Duration of postoperative ventilation > 48 hours or inability to obtain scale data on the first day after surgery

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. One-dimensional matrix vector composed of five frailty scale results

    Time frame: Before and after surgery, up to 2 weeks

    Consisting of five frailty scales: Edmonton frailty scale, FRAIL frailty scale, Fried frailty scale, Clinical frailty scale, and SPPB

Secondary outcomes

  1. 30-day adverse events

    Time frame: 30 days post operative

    Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure

  2. 1-year adverse events

    Time frame: 1 year post operative

    Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure

  3. EQ-5D score

    Time frame: 1 year post operative

    The score of EQ-5D questionnaire

  4. QOR-15 score

    Time frame: 1 year post operative

    The score of QOR-15 questionnaire

  5. Edmonton frailty scale score

    Time frame: 1 year post operative

    The Edmonton frailty scale consists of 11 items for a composite score of 0 to 17, and higher scores mean a worse outcome.

  6. FRAIL frailty scale score

    Time frame: 1 year post operative

    The FRAIL frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.

  7. Fried frailty scale score

    Time frame: 1 year post operative

    The Fried frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.

  8. Clinical frailty scale score

    Time frame: 1 year post operative

    The Clinical frailty scale is scored 1 to 9 based on a semiquantitative evaluation of the patient's symptoms, mobility, inactivity, exhaustion, and disability for basic activities of daily living and instrumental activities of daily living, and higher scores mean a worse outcome.

  9. Short Physical Performance Battery scale score

    Time frame: 1 year post operative

    The Short Physical Performance Battery scale consists of 3 physical tests, with each scored 0 to 4 for a composite score of 0 to 12, and higher scores mean a better outcome.

  10. Perioperative adverse events

    Time frame: From surgery to discharge, up to 7 days

    Including all cause death, stroke, renal insufficiency, deep sternal wound infection, and reoperation

  11. Area under receiver operating curve (AUC)

    Time frame: At the end of follow-up (1 mouth)

    Area under receiver operating curve of algorithm in predicting frailty scales and outcomes

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Frailty Assessment Tool for Patients Undergoing Cardiac Surgery Based on Artificial Intelligence Multimodal Non-contact Monitoring.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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