跳至主要内容
临床试验/NCT07452263
NCT07452263招募中不适用

Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery

University of Iceland1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
90-day Readmission

研究概览

简要总结

Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists.

The Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study.

We therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI <22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g/L for men and 120 g/L for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution.

This study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.
  • Patients assigned to undergo major surgery

排除标准

  • Cardiac surgery
  • Not undergoing planned surgery

研究组 & 干预措施

Frailty screening cohort undergoing major elective surgery

Patients ≥ 70 years undergoing major elective surgery who are triaged to present for preoperative assessment at the admissions department at Landspitali University Hospital in Iceland. Patients who screen positive on the mEFT (≥3 points) will be considered frail. Those who do not screen positive (≤2 points) will be part of the control group (non-frail).

干预措施: Major elective surgery (Procedure)

结局指标

主要结局

90-day Readmission

时间窗: From the day of surgery to postoperative day 90.

Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. Readmissions to the same hospital on the same day for the same principal diagnosis are not counted in the outcome.

Surgical Complications

时间窗: From the same day after surgery to postoperative day 30.

Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).

次要结局

  • Prolonged length of hospital stay(Postoperative day 0 through discharge from the index hospitalization (up to 180 days).)
  • 180-day mortality(Up to 180 days after the primary surgery)
  • Non-home discharge(From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Gísli Rabelo

Principal Investigator

University of Iceland

研究点 (1)

Loading locations...

相似试验

Modified Essential Frailty Toolset in Older Adults... | 临床试验