跳至主要内容
临床试验/CTRI/2020/02/023596
CTRI/2020/02/023596招募中不适用

A Prospective observational study designed to study the association between preoperative frailty and postoperative delirium in cardiac surgery patients.

BYL Nair Ch Hospital And TN Medical college Mumbai central1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
association between preoperative frailty and postoperative delirium in cardiac surgery patients.

研究概览

简要总结

Delirium is frequently seen postoperatively in cardiacsurgery patients, adding up to postoperative mortality and morbidity.

“Delirium is defined as an acute and overt change incognition and attention which may include alteration in consciousness anddisorganized thinking.â€

The unfavorable outcomes that follows post-operativedelirium includes prolonged hospitalization, increased rates of delayedinstitutional discharge, persistent functional and cognitive deficits,increased 30-day and 5-year mortality.This results in a substantial increase incost to the system.

According to current estimates, the incidence ofpostoperative delirium is 1 in 5 cardiac surgery patients .This necessitatespredicting patients susceptible to delirium preoperatively, so as to diagnoseand treat delirium early hence reducing post-operative morbidity.

There are different methods to predict patients susceptibleto delirium; one of such method is assessing frailty.

Frailty is defined as a state of decreased physiologicalreserves due to multisystem decline, which leaves patients in a state ofincreased vulnerability

Frailty consorts with multiple undesirable outcomes likecognitive decline, falls, fractures, and progressive disability in activitiesof daily living.

Presence of frailty increases the risk for post-operativecomplications of cardiac surgery such as inhospital mortality, institutional discharge,and reduced mid-term survival.

In this study, we would be doing a prospective observationalstudy to determine the effect of frailty on postoperative delirium in cardiacsurgery patients.

Frailty would be assessed by using following criteria:

  1. The Fried criteria

  2. Edmonton Frail Scale

  3. Short physical performance battery

  4. 35-item frailty index

And delirium would be assessed by usingConfusion assessment method (CAM)

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective cardiac surgery which includes cardiac bypass surgery and valvular heart disease repair surgery.

排除标准

  • Emergency Cardiac surgery.
  • K/C/O psychiatric illness.
  • Patients in whom delirium cannot be assessed reliably like patients with previous stroke, cerebral palsy, severe dementia, severe hearing disabilities, 4) Patients refusal to give consent.

结局指标

主要结局

association between preoperative frailty and postoperative delirium in cardiac surgery patients.

时间窗: 2 weeks

次要结局

未报告次要终点

研究者

发起方
BYL Nair Ch Hospital And TN Medical college Mumbai central
申办方类型
Government medical college

研究点 (1)

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