Assessment of Frailty in Elderly Patients Undergoing Elective Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Number of Participants with Operative Mortality or Major Morbidity
研究概览
简要总结
With increasing life expectancy, cardiac surgical procedures are increasingly being performed in older adults. The biological syndrome of frailty is an aging-associated state with diminished physiological reserve and resistance to stressors, such as major surgery. In the European System for Cardiac Operative risk Evaluation (EuroSCORE II) and the Society of Thoracic Surgeons (STS) risk scoring systems, patient comorbidities including advanced age and poor mobility are considered as risk factors for operative mortality. However, an objective assessment of frailty is not included. Traditionally, frailty assessment before cardiac surgery is primarily performed based on surgeon's subjective perception of patient's general appearance. Objective measurement of frailty is increasingly being applied as a routine part of preoperative evaluation of elderly patients undergoing cardiac surgery. The most widely used frailty assessment tool is the Fried scale. The investigators aim to investigate whether Fried scale would predict operative mortality and morbidity in elderly patients undergoing elective cardiac surgery.
详细描述
Consecutive patients who are scheduled to undergo elective cardiac surgery in Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital will be evaluated for enrollment. Those who meet inclusion and exclusion criteria will be invited to be study participants. Volunteers will constitute the study population. All participants will undergo routine preoperative risk assessment procedures of our institution, which include history, physical examination, blood chemistry, chest X-ray, echocardiogram, and spirometry. As part of this routine assessment, Fried scale (5-meter walk test, hand-grip strength, questioning of weight loss, short version of the Center for Epidemiological Studies-Depression scale, and short version of the Minnesota Leisure Time Physical Activity questionnaire) will be applied to all participants. Demographics characteristics and clinical data will be observed and recorded. Participants will be divided into 3 groups according to Fried scale; frail, moderately frail, and not frail.
In order to investigate the ability of Fried scale to predict cardiac operative mortality and morbidity, groups will be compared in terms of surgical mortality, renal failure, stroke, prolonged mechanical ventilation, deep sternal wound infections, re-operation, prolonged length of stay, and readmission rates.
Power analysis was performed to estimate sample size using G*Power (v3.1.7) software. A total 150 participants are needed in order to achieve an 80% (Beta=0.2) power at the 5% (Alpha=0.05) level of significance.
Categorical data will be presented as frequency and percentage. Continuous variables will be presented as mean [±standard deviation] and median [interquartile range]. Categorical variables will be compared using chi-square and Fisher's exact tests. Kolmogorov-Smirnov test will be used to assess distribution of continuous variables. Continuous variables with a normal distribution will be compared using Student's t-test, and those with a non-normal distribution will be compared using Mann-Whitney U test.
SPSS for Windows v.17.0 (SPSS Statistics Inc., Chicago, Ill., USA) will be used for all statistical analyses. A two-sided p value of <0.05 will be considered to be statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥65 years
- •Planned elective cardiac surgery
排除标准
- •Age<65 years
- •Emergent procedure
- •Refusal to participate
- •Clinical instability (recent myocardial infarction, decompensated cardiac failure, acutely symptomatic participants, abnormal vital signs)
- •Canadian Cardiovascular Society grade IV angina pectoris
- •New York Heart Association class IV heart failure
- •Failure to cooperate due to neuropsychiatric disorders
结局指标
主要结局
Number of Participants with Operative Mortality or Major Morbidity
时间窗: 30 days
Composite endpoint defined by The Society of Thoracic Surgeons. Operative mortality is defined as death occurring within 30 days after surgery, or during the same hospitalization following surgery. Major morbidity includes permanent stroke, renal failure, prolonged ventilation, deep sternal wound infection, re-operation for any reason.
次要结局
- Number of Participants with Prolonged Length of Stay(14 days)
- Number of Participants with Readmission to Intensive Care Unit(30 days)
- Number of Participants with Prolonged Length of Intensive Care Unit Stay(48 hours)
- Number of Participants with Readmission to hospital(30 days)
研究者
Kamile Ozeren Topcu
Principal Investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital