AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery
- Conditions
- Frailty
- Interventions
- Other: No intervention
- Registration Number
- NCT06096922
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Elective cardiac surgery
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AI frailty index establishment group No intervention Individuals who undergo elective cardiac surgury
- Primary Outcome Measures
Name Time Method One-dimensional matrix vector composed of five frailty scale results 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 Outcome Measures
Name Time Method 1-year adverse events 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
Edmonton frailty scale score 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.
Clinical frailty scale score 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.
Perioperative adverse events From surgery to discharge, up to 7 days Including all cause death, stroke, renal insufficiency, deep sternal wound infection, and reoperation
QOR-15 score 1 year post operative The score of QOR-15 questionnaire
30-day adverse events 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
EQ-5D score 1 year post operative The score of EQ-5D questionnaire
FRAIL frailty scale score 1 year post operative The FRAIL frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.
Fried frailty scale score 1 year post operative The Fried frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.
Short Physical Performance Battery scale score 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.
Area under receiver operating curve (AUC) At the end of follow-up (1 mouth) Area under receiver operating curve of algorithm in predicting frailty scales and outcomes
Trial Locations
- Locations (1)
Fuwai hospital
🇨🇳Beijing, Beijing, China