AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Shen Lin, MD, PhD; Phone Number: +86 88398027; Email: linshen@fuwai.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Fuwai Hospital
      • Contact: Shen Lin, MD, PhD; Phone Number: +86 18800161211; Email: Linshen@fuwai.com
      • Contact: Runchen Sun, MD, PhD; Phone Number: +86 18801223231; Email: 18801223231@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient aged 18 years or older, undergoing elective cardiac surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AI frailty index establishment group; Individuals who undergo elective cardiac surgury	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-dimensional matrix vector composed of five frailty scale results	Consisting of five frailty scales: Edmonton frailty scale, FRAIL frailty scale, Fried frailty scale, Clinical frailty scale, and SPPB	Before and after surgery, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day adverse events	Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure	30 days post operative
1-year adverse events	Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure	1 year post operative
EQ-5D score	The score of EQ-5D questionnaire	1 year post operative
QOR-15 score	The score of QOR-15 questionnaire	1 year post operative
Perioperative adverse events	Including all cause death, stroke, renal insufficiency, deep sternal wound infection, and reoperation	From surgery to discharge, up to 7 days
Area under receiver operating curve (AUC)	Area under receiver operating curve of algorithm in predicting frailty scales and outcomes	At the end of follow-up (1 mouth)
Edmonton frailty scale score	The Edmonton frailty scale consists of 11 items for a composite score of 0 to 17, and higher scores mean a worse outcome.	1 year post operative
FRAIL frailty scale score	The FRAIL frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.	1 year post operative
Fried frailty scale score	The Fried frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.	1 year post operative
Clinical frailty scale score	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.	1 year post operative
Short Physical Performance Battery scale score	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.	1 year post operative

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Shen Lin, MD, PhD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Artificial intelligence; Frailty; Cardiac surgery; Non-contact monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2023-GSP-RC-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No