Predicting increased length of stay and adverse outcome in Indian Geriatric patients coming for surgery: A prospective case control study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess admission frailty and its association with increased length of hospital stay.
研究概览
简要总结
According toPopulation Census 2011, there are nearly 104 million elderly persons (aged 60years or above) in India; 53 million females and 51 million males. A reportreleased by the United Nations Population Fund and Help Age India suggests thatthe number of elderly persons is expected to grow to 173 million by 2026 and to300 million by 2050.
Older patientshave worse outcomes than younger patients, with higher mortality, highercomplications rates, adverse discharge outcomes and longer hospital stay. Development of adverseoutcomes in the geriatricpopulation cannot be explained solely by advanced age. Concomitantly,surgical practice patterns have evolved to prioritize the maximization ofdisease management over the potential risks of surgery in the elderly. The large andincreasing proportion of surgicalprocedures performed on this aging population of patients has made it incumbent on the anaestheticand surgical community to improve risk stratification. Therefore, we continueto seek additional factors that may predict apatient’s perioperative risk for major adverse events.
Frailty, inparticular, has become an area of increased interest. Frailty is a multidimensionalstate of loss of physiologic reserves including energy, physicalability, cognition, and health that gives rise tovulnerability to poor health outcomes due to a decreased ability to withstandphysiologic stress. But, there is no universal definition offrailty because assessments offrailty range from the very simple (number of outpatient medications) to therelatively complex (scoredclock-drawing test).6There is consensus that frailty, as measured by any number of these metrics, isassociated with adverse perioperative outcomes including major morbidity,mortality, and increased length of stay.Therefore weplanned a study to assess the adverse outcomes in geriatric population by assessing the frailty.
Patients will beassessed and screened for frailty at the time of pre-anaesthetic check-up,prior to the surgery. Frailty will be assessed by the CFS and F1 LAB scores.Assessors may not be present daily and data will be collected on days thepatient will be operated. Some of patients who will get re-do for the samesurgery, will also be considered. A smallnumber of patients may be operated for > 1 procedure after assessment, thesurgery with higher complexities will be used. The Clinical frailty scale and the F1 LAB are defined below.
Clinical Frailty Scale:
The geriatrician determines the CFSscore during the initial consultation, through history obtained from thepatient, family, and/or other health care providers about comorbidities, energylevel, and functional status. CFS scores of patients at theincluded in the study were abstracted from the comprehensive geriatricassessment. If the value was not available in the consultation note, a manualchart review was conducted to assign the score. Two raters independentlydetermined the CFS score of each patient, and a third study author adjudicatedany remaining conflicts after reconciliation of the scores. The CFS scores werestratified into 3 groups based on the CFS validation study13: 1 to 3 were “not frail,†4 and 5were “at risk to mildly frail,†and 6 and 7 were “frail.†The “at risk tomildly frail†group was separated into “apparently vulnerable†(CFS 4) and“mildly frail†(CFS 5) in the descriptive statistics and unadjusted analyses.(Appendix1)
Laboratory Frailty Index
The 23-item laboratory Frailty Index(FI-lab) was calculated based on first available values within 48 hours ofpresentation to hospital. The FI-lab was modified from the original versiondescribed by Howlett and colleagues14 to accommodate laboratory values readily availablefor a trauma patient. The venereal disease research laboratory test, T4, folate, and RBC folate wereremoved because very few patients had these parameters measured. These 4variables were replaced by troponin,international normalized ratio, venous lactate,and oxygen saturation becausethey are commonly measured in the setting of trauma and meet the criteria forinclusion in a deficit accumulation frailty index (Table 1).11 AdmissionFI-lab was calculated as described previously14 andwas stratified into 3 groups according to the system proposed by Searle andassociates15: FI < 0.25 is mild frailty, 0.25 ≤ FI ≤ 0.4 is moderate frailty, andFI > 0.4 is severe frailty. (Appendix2)
Patient will be followed aftersurgery. All the in hospitalcomplications should be noted and also the total length of stay including wardand ICU. Patients co morbid condition and the multiple drugs he is taking willbe noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Age > 60 years.
- •More than equal to 3 Prescribed medications
- •Impaired mobility.
排除标准
- •1.Patient who died within 48 hours.
- •2.Length of hospital stay less than 3 days.
结局指标
主要结局
To assess admission frailty and its association with increased length of hospital stay.
时间窗: At the time of admission and at the time of discharge/death
次要结局
- To asses whether frailty is associated with in hospital complications and with adverse discharge disposition.(1 year)
