Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

NCT ID: NCT05742737

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-04-01

Brief Summary

This study is a observational study in China, which aims to explore the predictive effect of preoperative frailty defined by the modified frailty index in predicting postoperative survival and complications in elderly patients.

The objectives of the study include:

1. To demonstrate that the frailty scale can predict short- and long-term survival after surgery in elderly surgical patients; 2 Demonstrated that frailty as defined by this scale is associated with postoperative complications in older patients

Detailed Description

Traditionally, frailty has been described as the form of chronological age. Evaluating the patient's risks based solely on age is difficult, several other factors contribute to physiologic aging and determine functional reserve and response to the risk of postoperative complications. To meet the clinical demand for simpler frailty measurement tools, a simplified 5-index modified frailty index (mFI-5) has been proposed and validated in many literatures. However, there is a lack of evidence on the link between preoperative weakness and poor prognosis in elderly patients undergoing non cardiac surgery.

Therefore, the purpose of this study is to verify the prognostic value of mFI-5 for short-term and long-term adverse outcomes such as postoperative delirium, anxiety, depression, acute pain, and mortality in elderly non-cardiac surgery patients. Our hypothesis is that frailty may be highly correlated with postoperative mortality and adverse outcomes in elderly patients undergoing non-cardiac surgery, and that mFI-5 may be an effective risk prediction tool for decision-making and surgical planning.

Conditions

Frailty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Robust

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

No interventions assigned to this group

Prefrail

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

Frailty Index

Intervention Type: OTHER

The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database

frail

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

Frailty Index

Intervention Type: OTHER

The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database

Interventions

Frailty Index

The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

(1) participants ≥ 65 years of age;

Exclusion Criteria

1. lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);

2. ASA physical status Ⅴ;

3. Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;

4. Surgery time ≤ 60 min.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weidong Mi

OTHER

Sponsor Role: lead

Responsible Party

Weidong Mi

Director of anesthesiology department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Weidong Mi, PhD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PLAGH-Frailty

Identifier Type: -

Identifier Source: org_study_id