Clinical trial NCT06096922: AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery
Official title: Frailty Assessment Tool for Patients Undergoing Cardiac Surgery Based on Artificial Intelligence Multimodal Non-contact Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: Frailty
Cardiac surgery
Artificial intelligence
Non-contact monitoring
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-10-24
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 18 years or older, undergoing elective cardiac surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: One-dimensional matrix vector composed of five frailty scale results
timeFrame: Before and after surgery, up to 2 weeks
Secondary outcomes:
measure: 30-day adverse events
timeFrame: 30 days post operative
measure: 1-year adverse events
timeFrame: 1 year post operative
measure: EQ-5D score
timeFrame: 1 year post operative
measure: QOR-15 score
timeFrame: 1 year post operative
measure: Edmonton frailty scale score
timeFrame: 1 year post operative
measure: FRAIL frailty scale score
timeFrame: 1 year post operative
measure: Fried frailty scale score
timeFrame: 1 year post operative
measure: Clinical frailty scale score
timeFrame: 1 year post operative
measure: Short Physical Performance Battery scale score
timeFrame: 1 year post operative
measure: Perioperative adverse events
timeFrame: From surgery to discharge, up to 7 days
measure: Area under receiver operating curve (AUC)
timeFrame: At the end of follow-up (1 mouth)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shen Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: