AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096922
• Other study ID #: 2023-GSP-RC-10
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Shen Lin, MD, PhD
• Phone: +86 88398027
• Email: linshen[@]fuwai.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	EQ-5D score	The score of EQ-5D questionnaire	1 year post operative
Secondary	QOR-15 score	The score of QOR-15 questionnaire	1 year post operative
Secondary	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
Secondary	FRAIL frailty scale score	The FRAIL frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.	1 year post operative
Secondary	Fried frailty scale score	The Fried frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.	1 year post operative
Secondary	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
Secondary	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
Secondary	Perioperative adverse events	Including all cause death, stroke, renal insufficiency, deep sternal wound infection, and reoperation	From surgery to discharge, up to 7 days
Secondary	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)