跳至主要内容
临床试验/CTRI/2024/04/065364
CTRI/2024/04/065364尚未招募不适用

Proportion of Postoperative Delirium(POD) in Elderly Orthopedic Patients and Use of the PROPDESC Risk Assessment Tool to Predict POD.

Believers Church Medical College Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
1. Proportion of Post-operative delirium among elderly patients undergoing elective lower limb surgeries.

研究概览

简要总结

Post-operative delirium (POD) is a common complication of elderly patients with reported incidence ranging from 15% to 50%. It is associated with adverse outcomes, including longer length of hospital stay, decline in function and cognition, increased risk of nursing home placement, and death. Patients older than 70 years of age with hip fractures have more than threefold increased risk of developing POD and the hypoactive subtype is more likely to develop in people over the age of 80 . Screening tools for predicting risk of POD should consider ease of implementation in a busy preoperative setting.  The MoCA(Montreal Cognitive Assessment), the MMSE(Mini Mental State Examination) and mini-Cog tests have been studied in the peri-operative setting  for assessment of cognition. However, the latter two are more time consuming and not freely available for use.  Most commonly reported tools for the diagnosis of POD include CAM score, 4AT, besides other tools like Delirium detection scale(DDS). Limited Indian data exist on the incidence of POD.

The aim of this study is to find the proportion of patients developing post-operative delirium among those undergoing elective orthopaedic lower limb surgeries and the effectiveness of a risk assessment tool PROPDESC to predict development of post- operative delirium in such patients. This will help identify at risk patients and therefore modify peri-operative management. Study tools used- PRe-Operative Prediction of post-operative DElirium by appropriate SCreening( PROPDESC), Montreal Cognitive Assessment (MoCA), Confusion Assessment Method(CAM).  All the patients meeting the inclusion and exclusion criteria will be enrolled. On the day before surgery, Informed consent for delirium assessment will be obtained. In addition to the routine Pre-Anaesthetic evaluation, the PROPDESC score will be calculated using Age, ASA Classification, NYHA Classification, Surgical risk and Montreal Cognitive Assessment (MoCA) Intraoperatively, the type and duration of surgery and of anaesthesia, as well as intra-operative complications, if any, will be noted. Postoperatively, patients will be interviewed with CAM-Sand 4AT on postoperative days 1, 3 and 5. Patients with at least one postoperative interview will be included in the analysis. Outcome parameters noted will include, occurrence of any post-operative complications, length of hospital stay and death/ discharge. Total costs of hospitalisation will also be

noted.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients aged above 60 years undergoing elective orthopaedic lower limb surgeries ASA(PS)1-3 Duration of surgery less than 240 minutes or 4 hours.

排除标准

  • Emergency procedures Pre-existing dementia, delirium or disorders of consciousness or any neurological disorders which prevent adequate cognitive testing and delirium assessment.
  • Post-operative requirement of ICU or HDU care/ ventilatory support/ any form of sedation.
  • Language barriers Had undergone surgery in the past 3 months.
  • Patient refusal to participate.

结局指标

主要结局

1. Proportion of Post-operative delirium among elderly patients undergoing elective lower limb surgeries.

时间窗: 18 months for studying proportion of post-operative delirium in elderly patients undergoing elective lower limb surgeries.

2.What is the effectiveness of the pre-operative PROPDESC tool in predicting post-operative delirium in elderly patients undergoing elective lower limb surgeries.

时间窗: 18 months for studying proportion of post-operative delirium in elderly patients undergoing elective lower limb surgeries.

3. To explore association of risk factors in elderly undergoing elective lower limb orthopaedic surgeries.

时间窗: 18 months for studying proportion of post-operative delirium in elderly patients undergoing elective lower limb surgeries.

次要结局

  • Comparison of outcomes, post-operative complications, length of hospital stay and cost of treatment between patients who developed delirium versus those who did not.(18 months)

研究者

发起方
Believers Church Medical College Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Gowri P M

Believers Church Medical College Hospital

研究点 (1)

Loading locations...

相似试验