AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096922
Collaborator
(none)
500
1
14
35.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Frailty Assessment Tool for Patients Undergoing Cardiac Surgery Based on Artificial Intelligence Multimodal Non-contact Monitoring.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
AI frailty index establishment group

Individuals who undergo elective cardiac surgury

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. EQ-5D score [1 year post operative]

    The score of EQ-5D questionnaire

  4. QOR-15 score [1 year post operative]

    The score of QOR-15 questionnaire

  5. 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.

  6. FRAIL frailty scale score [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 [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 [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 [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 [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) [At the end of follow-up (1 mouth)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fuwai hospital Beijing Beijing China 100032

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Shen Lin, MD, PhD, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT06096922
Other Study ID Numbers:
  • 2023-GSP-RC-10
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by China National Center for Cardiovascular Diseases
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023