Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population
- Conditions
- Frailty
- Interventions
- Other: Frailty Index
- Registration Number
- NCT05742737
- Lead Sponsor
- Weidong Mi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12000
(1) participants ≥ 65 years of age;
- lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);
- ASA physical status Ⅴ;
- Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;
- Surgery time ≤ 60 min.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prefrail Frailty Index 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. frail Frailty Index 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.
- Primary Outcome Measures
Name Time Method 1-month all-cause mortality postoperative 1-month 1-month postoperative mortality in elderly patients over 65 years of age
12-month all-cause mortality postoperative 12-month 12-month postoperative mortality in elderly patients over 65 years of age
6-month all-cause mortality postoperative 6-month 6-month postoperative mortality in elderly patients over 65 years of age
- Secondary Outcome Measures
Name Time Method Readmission rates postoperative 30-day The rate of second admissions in elderly patients over 65 years old who underwent surgery within 30 days after surgery
Admission to ICU From the moment of living operation room to the moment of discharge from hospital,up to 7 day Elderly surgical patients over the age of 65 are admitted to the intensive care unit after surgery
major complications From the moment of living operation room to the moment of discharge from hospital,up to 7 day Postoperative complications include delirium, anxiety, depression, acute pain, stroke, major adverse cardiac events, acute kidney injury, infection, etc
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China