跳至主要内容
临床试验/CTRI/2023/03/050901
CTRI/2023/03/050901尚未招募不适用

A prospective observational study on the incidence of delirium among the patients in intensive care unit.

SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年1月5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
220
试验地点
1
主要终点
Incidence of delirium

研究概览

简要总结

The patients who qualify as perthe selection criteria will be given a clear explanation in their vernacularlanguage. A written consent will be obtained in each case.

The following information will be collected uponadmission: sex, date of admission, category of admission, diagnosis,description of previous and current use of sedatives or antipsychotic drugs,other medication used, Acute Physiological and Chronic Health Evaluation II(APACHE II) score, presence of invasive procedures, monitoring data, and typeof organ support.

Patients eligible for the study will beevaluated to detect delirium using the Confusion Assessment Method (CAM)‑ICUdaily.

CAM-ICU method will be done by the principalinvestigator and will record the scores till the patient gets discharged.Thediagnosis of the delirium will be done by the physicians.

It is an instrument simple to use; the scorevaries from 1 to 7: level (1) refers to a patient who cannot respond to voiceor physical stimulation and (7) to a combative violent patient. Every patientwill be daily evaluated until his/her RASS score is ≥4, so he/she can beassessed for delirium using the CAM‑ICU.

THE FOLLOWING PARAMETERSWILL BE COLLECTED

1.HEART RATE

2.BLOOD PRESSURE

3.SPO2

4.RESPIRATORY RATE

5.HB

6.HCT

7.TC

8.DC

9.PLATELET

10.LFT

11.RFT

12.INR

13.BUN/CREATININE

14.UREA

15.SODIUM

16.POTASSIUM

17.1MAGNESIUM

18.CALCIUM

19.APACHE II

20.CAM-ICU SCORE

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients in age group above 18 years •Patients who had Richmond agitation and sedation scale (RASS) score between -2 and +4.

排除标准

  • •Patients who had been treated with antipsychotic drugs within the previous 10 days •Patients who had history of dementia •Patients who were suffering from acute alcohol withdrawal syndrome, •Patients who had delirium or serious auditory or visual disorders before ICU admission •Patients who were unable to understand the Tamil or English languages •Patients were severely mentally disabled, suffered from a terminal illness, •Patients of age group < 18 years.

结局指标

主要结局

Incidence of delirium

时间窗: Incidence of delirium from 48 hours after admission in ICU till discharge from ICU

次要结局

  • Risk factors associated with delirium(validation of CAM ICU score)

研究者

发起方
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
申办方类型
Research institution and hospital

研究点 (1)

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