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临床试验/CTRI/2025/02/081210
CTRI/2025/02/081210尚未招募不适用

Incidence of delirium and postoperative outcomes in head neck cancer surgical patients- A prospective observational study

ACTREC Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
试验地点
1
主要终点
1. Study the incidence of Delirium in postoperative adult head and neck surgical patients

研究概览

简要总结

Patients undergoing major head and neck onco-surgeries can have significant postoperative morbidity. Delirium, a neuropsychiatric syndrome, is definedas a disturbance in attention, awareness, and cognition that develops over a short period oftime and fluctuates in severity. It is transient and usually reversible. Delirium in critically care population is reported between 20 to 40%. It can be either hyperactive, hypoactive or mixed type. It is important to assess delirium as it can have negative impact on the outcome and recovery from critical illness. We are using the CAM-ICU score to detect delirium in out population. We will study the incidence of delirium, the impact in post op outcome and risk factors associated with it. The data will be collected over a period of 1 year in ACTREC, Tata Memorial Centre. The data will be collected from the case record form and there will be no direct patient contact. Data will be maintained securely and will not be disclosed at any point during the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All adult postoperative head neck patients admitted to recovery room or ICU for more than 24 hrs.

排除标准

  • Patients with prior psychiatric illness or patients on medications that will influence delirium.

结局指标

主要结局

1. Study the incidence of Delirium in postoperative adult head and neck surgical patients

时间窗: Data will be collected over a period of 1 year

2. To evaluate the impact of delirium on various post-operative outcome, including: Length of hospital stay, rate of complication (e.g. Infection, respiratory issues), need for additional interventional (e.g. Reoperation)

时间窗: Data will be collected over a period of 1 year

3. Risk factor identification: identify risk factors for developing delirium, such as age, comorbidity, medication use, and surgical complexity.

时间窗: Data will be collected over a period of 1 year

次要结局

  • 1. 30-day Clavien Dindo complication rate(2. ICU & Hospital length of stay & outcomes)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Malini Joshi

Tata Memorial Centre

研究点 (1)

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